[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-with-preserved-ejection-fraction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-with-preserved-ejection-fraction":607},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,76,0,25,[9,49,74,110,144,172,192,217,240,261,288,308,329,350,368,393,409,426,448,464,486,509,531,557,577],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100595823",false,"NCT07037459","Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)","MARITIME-HF","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent.\n* BMI ≥ 30.0 kg\u002Fm\\^2 at randomization.\n* HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.\n* Managed with HF standard of care therapies.\n* Left ventricular ejection fraction (LVEF) of \\> 40% within 12 months before randomization.\n\nExclusion Criteria:\n\n* History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.\n* HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy\u002Fdysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.\n* Hospitalized with acute decompensated HF at the time of or during the screening period.\n* Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.\n* For participants with a prior diagnosis of T2DM (including those diagnosed during screening):\n\n  1. HbA1c \\> 10.0% (86 mmol\u002Fmol) at screening\n  2. Uncontrolled diabetes requiring immediate therapy\n  3. History of diabetic ketoacidosis or hyperosmolar state\u002Fcoma within 12 months before randomization\n  4. One or more episodes of severe hypoglycemia within 6 months before randomization and\u002For history of hypoglycemia unawareness\n  5. History or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic retinopathy and\u002For macular edema.\n* SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP \\> 160 mmHg during the screening period (including day 1 prior to randomization).\n* History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.\n* Any personal lifetime history of, or family history(first-degree relative\\[s\\]) of medullary thyroid carcinoma or MEN-2.\n* eGFR \\\u003C 20 mL\u002Fmin\u002F1.73 m\\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.\n* Calcitonin ≥ 50 ng\u002FL (pg\u002FmL) at screening.\n* Acute or chronic hepatitis.\n* Any of the following psychiatric history:\n\n  1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period\n  2. Lifetime history of suicide attempt\n  3. History of non-suicidal self-injury within 5 years prior to screening or during the screening period.\n* History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.\n* Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days prior to or during the screening period or planned use during the conduct of the trial.","ALL","18 Years","99 Years",{"count":21,"type":22},5056,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.",[28,29,30],"Heart Failure With Preserved Ejection Fraction","Heart Failure With Mildly Reduced Ejection Fraction","Obesity",[32,30,33,34,35],"Heart Failure","Maridebart Cafraglutide","AMG 133","MariTide","RECRUITING","2026-06-30",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":40},"2025-06-25",{"date":44,"type":22},"2030-09-29",{"name":46,"class":47},"Amgen","INDUSTRY",628,{"id":50,"slug":4,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100479644","NCT05525663","Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction","Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection","REHAB-HFpEF","Inclusion Criteria:\n\n1. Age \\>=60 years old\n2. Ejection Fraction \\>=45%\n3. In the hospital setting \\>24 hours for the management of acute decompensated heart failure (ADHF), or diagnosed with ADHF after being hospitalized for another reason. ADHF will be confirmed by the site physician, and will be defined according to the Food and Drug Administration (FDA) definition of hospitalized heart failure as a combination of symptoms, signs, and HF-specific medical treatments, and requires that all 4 of the following are met:\n\n   * At least 1 symptom of HF which has worsened from baseline: a. dyspnea at rest or with exertion; b. exertional fatigue; c. orthopnea; d. paroxysmal nocturnal dyspnea (PND)\n   * At least 2 of the following signs of HF: a. Pulmonary congestion or edema on physical exam (rales or crackles) or by chest X-ray; b. Elevated jugular venous pressure or central venous pressure \\>=10 mm Hg; c. peripheral edema; d. wedge or left ventricular end diastolic pressure \\>=15 mmHg; e. rapid weight gain (\\>=5 lbs.); f. Increased b-type natriuretic peptide (BNP) (\\>=100 pg\u002Fml) or N-terminal prohormone BNP (\\>=220pg\u002Fml)\n   * Change in medical treatment specifically targeting HF, defined as change in dose or initiation of or augmentation of at least 1 of the following therapies: a. diuretics; b. vasodilators; c. other neurohormonal modulating agents, including angiotensinconverting enzyme inhibitors, angiotensin II receptor blockers (with or without neprilysin inhibitor), beta-blockers, aldosterone inhibitors, direct renin inhibitors, or sodium-glucose co-transporter-2 inhibitors\n   * The primary cause of symptoms and signs is judged by the investigator to be due to HF\n4. Adequate clinical stability to allow participation in study assessments and the intervention Independent with basic activities of daily living, including the ability to ambulate independently (with or without the use of an assistive device) prior to admission\n5. Able to walk 4 meters (with or without the use of an assistive device) at the time of enrollment\n\nExclusion Criteria:\n\n1. Acute myocardial infarction within the past 3 months, or planned coronary artery intervention (percutaneous or surgical) within the next 6 months (Note: given that cardiac biomarkers such as troponin are frequently elevated in HF patients, the diagnosis of acute myocardial infarction should be based on clinical diagnosis, not biomarkers alone)\n2. Severe aortic or mitral valve stenosis\n3. Severe valvular heart disease with planned intervention within next 6 months\n4. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis)\n5. Planned discharge other than to home or a facility where the participant will live independently\n6. Terminal illness other than HF with life expectancy \\\u003C1 year\n7. Impairment from stroke or other medical disorders that preclude participation in the intervention\n8. Known dementia by medical record documentation, OR patients with Montreal Cognitive Assessment (MoCA) \\\u003C=18 AND without social support, OR MoCA \\\u003C10 regardless of social support\n9. Advanced chronic kidney disease defined as estimated glomerular filtration rate \\\u003C20 mL\u002Fmin\u002F1.73 m2 or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months\n10. Already engaging in regular moderate to vigorous exercise conditioning defined as \\>30 minutes per day, \\>= twice per week consistently during the previous 6 weeks\n11. Enrollment in a clinical trial not approved for co-enrollment\n12. High risk for non-adherence as determined by screening evaluation\n13. Inability or unwillingness to comply with the study requirements or give consent","60 Years",{"count":58,"type":22},880,[60],"NA","The REHAB-HFpEF trial will determine whether a novel physical rehabilitation intervention will improve the primary outcome of combined all-cause rehospitalizations and mortality and the secondary outcome of major mobility disability during 6-month follow-up in patients hospitalized for heart failure and preserved ejection fraction (HFpEF), which is nearly unique to older persons, and for which there are few treatment options.",[28],"2026-06-24",{"date":65,"type":40},"2026-06-29",{"date":67,"type":40},"2023-02-16",{"date":69,"type":22},"2028-01",{"name":71,"class":72},"Wake Forest University Health Sciences","OTHER",1,{"id":75,"slug":4,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100444229","NCT05064709","Assessment of CCM in HF With Higher Ejection Fraction","Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction","AIM HIGHer","Inclusion Criteria:\n\n1. Signed and dated informed consent form;\n2. Male or non-pregnant female, 18 years or older;\n3. Diagnosed with symptomatic heart failure;\n4. LVEF ≥40 and ≤70% (as assessed by site echo);\n5. A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table 1 in Section 9.2.6)\n6. Subjects must meet one of the following conditions:\n\n   * Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance.\n   * Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed appropriate by the clinician in response to symptoms or weight gain) Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event.\n\nExclusion Criteria:\n\n1. Resting ventricular rate \\\u003C50 or \\>110 bpm;\n2. Resting systolic blood pressure \\\u003C100 or ≥160 mmHg;\n3. BMI greater than 46\n4. Any severe valvular stenotic disease or any severe valvular regurgitation;\n5. Mechanical tricuspid valve;\n6. Complex congenital heart disease;\n7. Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and\u002For exercise intolerance;\n8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;\n9. A KCCQ CCS score higher than 85;\n10. Hypertrophic, infiltrative\u002Frestrictive or inflammatory cardiomyopathy;\n11. Unstable angina pectoris within 30 days prior to study consent;\n12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;\n13. Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects with active\u002Fongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as NYHA class III or higher.\n14. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;\n15. Myocardial infarction within 90 days prior to study consent;\n16. Prior heart transplant or ventricular assist device;\n17. Planning to become pregnant during the study;\n18. Dialysis (permanent) or GFR \\\u003C15 ml\u002Fmin\u002F1.73m2;\n19. Participating in another investigational drug or device study that may interfere with the interpretation of study data;\n20. Currently undergoing active chemotherapeutic and\u002For radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent;\n21. Expected lifespan of less than 18 months from time of study consent;\n22. Unable to follow through study protocol for any reasons in the investigator's judgement.",{"count":82,"type":22},1500,[60],"The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.",[32,28,86,87,88],"Heart Failure With Mid Range Ejection Fraction","Heart Failure With Moderately Reduced Ejection Fraction","Diastolic Heart Failure",[90,91,92,93,94,95,96,97,98,99,100],"HFpEF","Heart failure","CCM","CCM therapy","cardiac contractility modulation","symptomatic heart failure","left ventricular ejection fraction","LVEF","Optimizer","Optimizer Smart Mini","Quality of Life",{"date":102,"type":40},"2026-06-26",{"date":104,"type":40},"2022-02-03",{"date":106,"type":22},"2029-02-01",{"name":108,"class":47},"Impulse Dynamics",105,{"id":111,"slug":4,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":141,"locationsCount":143},"100507429","NCT05887271","A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction","A Multi-Ethnic, Multi-centre raNdomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction (AMEND-preserved)","AMEND","Inclusion Criteria:\n\n1. Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF\\>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse\n2. Clinically stable for ≥ 3 months (no admissions to hospital)\n3. Obesity (BMI ≥30kg\u002Fm2 if white European or ≥27kg\u002Fm2 if Asian, Middle Eastern or Black ethnicity)\n4. Age ≥18\n\nExclusion Criteria:\n\n1. Inability to walk\u002Fundertake 6-minute walk test\n2. Inability to follow a low-energy MRP\n3. HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy\u002Fpericardial disease or congenital heart disease.\n4. Recovered EF (previous EF \\\u003C 40%) unless reduced EF was in context of tachycardia induced cardiomyopathy (eg AF\u002FAflutter).\n5. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension\n6. Severe chronic obstructive pulmonary disease (FEV1\\\u003C 1.0L)\n7. Severe primary valvular heart disease\n8. Anaemia (Hb\\\u003C100g\u002FL)\n9. Severe renal disease (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2)\n10. Weight loss \\> 5kg in preceding 3 months.\n11. Symptomatic gallstones (including biliary colic) or cholecystitis within last 3 months\n12. Active substance abuse (drugs or alcohol)\n13. History of bariatric surgery in the last 3 years\n14. Active illness likely to cause change in weight\n15. Women who are pregnant or are considering pregnancy\n16. People currently participating in another clinical research trial that is likely to affect diet or weight change.\n17. History of a severe mental illness including an eating disorder\n\n17\\. Individuals with a diagnosis of Type 1 diabetes mellitus.",{"count":118,"type":22},63,[120,25],"PHASE2","Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle unable to relax efficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot data in patients with obesity and diabetes and a small number of patients with HFpEF have shown improvements in exercise capacity and reversal of changes in the heart and blood vessels. This study will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. A total of 63 adults will be invited and allocate by chance into two groups: 1) 12-weeks of a low calorie diet or 2) Standard care and health advice on how to lose weight followed by the option to have the low calorie diet after 12-weeks. The study will determine if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. Additionally, participants' views on changing their diet and how this has impacted their symptoms will be sought during the study in an optional interview. This will help guide treatments planning in the future to get maximum benefits, and to individualize support to patients from different cultural backgrounds.",[28,123,124,125,126],"Heart Failure, Diastolic","Diabetes Mellitus, Type 2","Diabetes Mellitus Type 2 in Obese","Obesity Adult Onset",[128,129,130,30,131,132,133,134],"Heart failure with preserved ejection fraction","Diastolic heart failure","Type 2 diabetes mellitus","Meal replacement plan","Cardiac magnetic resonance imaging","Exercise intolerance","Diabetes remission","2026-06-22",{"date":137,"type":40},"2026-06-25",{"date":139,"type":40},"2023-12-05",{"date":37,"type":22},{"name":142,"class":72},"University of Leicester",3,{"id":145,"slug":4,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":4},"100612505","NCT07254455","CASTLE-HFpEF (Catheter Ablation for Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction)","Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Left Ventricular Ejection Fraction - A Prospective, Randomized, Multi-national Study Using Two Systems for Rhythm Monitoring","Inclusion Criteria:\n\n1. ≥18 years of age at screening visit.\n2. Clinical signs and symptoms of HF (26).\n3. Left ventricular ejection fraction (LVEF) \\>40% within the past 12 months (most recent LVEF measurement)\n4. Elevated NT-proBNP levels during screening or within 12 months prior to screening (most recent value; blood test):\n\n   * For patients in normal sinus rhythm (NSR) at the time of blood sampling: NT proBNP ≥300 pg\u002FmL\n   * For patients in AF at the time of blood sampling: NT-proBNP ≥600 pg\u002FmL\n5. Echocardiographic evidence of HFmrEF\u002FHFpEF, with at least one of the following during screening or within the 12 months prior to screening:\n\n   1. Left atrial volume index (LAVI) ≥34 mL\u002Fm2 for patients in NSR, or LAVI ≥40 mL\u002Fm2 for patients in AF.\n   2. Tricuspid regurgitation (TR) peak velocity \\>2.8 m\u002Fs.\n   3. Mitral E\u002Fe' ratio at rest ≥9.\n   4. Left ventricular mass index (LVMI) ≥115 g\u002Fm2 for men and ≥95 g\u002Fm2 for women.\n   5. Septal thickness or posterior wall thickness ≥1.1 cm.\n6. Patients previously diagnosed with persistent AF since ≤4 months prior to screening with an indication for anticoagulation, OR Patients previously diagnosed with paroxysmal AF since ≤4 months prior to screening with an already known AF burden of ≥1% and\u002For an AF episode of ≥24 hours, with an indication for anticoagulation OR Patients with paroxysmal AF without known AF burden (diagnosed since ≤4 months prior to screening) or no previously diagnosed AF who are subsequently diagnosed with AF after receiving a single-lead electrocardiography (ECG) patch for 30 days. These patients should have an AF burden of ≥1% and\u002For an AF episode of ≥24 hours on the ECG patch (more details down below in section 8.1.1) and an indication for anticoagulation.\n7. Stable optimal medical therapy for HFmrEF\u002FHFpEF for at least 4 weeks (diuretics \\& SGLT2 inhibitors unless contraindicated; angiotensin receptor-neprilysin inhibitors \\& mineralocorticoid receptor antagonists as deemed appropriate by the treating physician; Amiodarone and Beta-blockers are not considered for defining heart failure therapy).\n8. Signed written informed consent obtained from the participant or participant's legal representative and ability for participant to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Participants will be excluded from the study for any of the following reasons:\n\n  1. Previous catheter ablation for AF.\n  2. Known infiltrative cardiomyopathy, hypertrophic cardiomyopathy and amyloidosis.\n  3. Documented left atrial diameter \\>6cm.\n  4. Any contraindication for chronic anticoagulation therapy or heparin, including hypersensitivity to any of the components.\n  5. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.\n  6. Planned cardiovascular intervention during the follow-up period.\n  7. Patients with severe valvular disease\n  8. Life expectancy ≤12 months.\n  9. Untreated hypothyroidism or hyperthyroidism (blood test).\n  10. Requirement for dialysis due to end-stage chronic kidney disease.\n  11. Mental or physical inability to participate in the study.\n  12. Women currently pregnant (blood test) or breastfeeding or not using reliable contraceptive measures during fertility age.\n  13. Enrollment in another investigational drug or device study within the last 30 days before registration.\n  14. Medical or psychological conditions that would not permit the participant to complete the study or sign informed consent.\n  15. Known alcohol or drug abuse.\n  16. Presence of a condition, abnormality or disease that in the opinion of the investigator would compromise the safety of the participant or the quality of the data.\n  17. Legal incapacity or limited legal capacity.","120 Years",{"count":152,"type":22},900,[60],"The clinical equipoise in the treatment of Atrial Fibrillation (AF) in patients with Heart Failure with mildly reduced Ejection Fraction\u002FHeart Failure with Preserved Ejection Fraction (HFmrEF\u002FHFpEF) reflects the scarcity of randomized trials on different treatment modalities. By generating high-quality, evidence-based, randomized data on the impact of treatment on hard outcomes, Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients with Heart Failure with Preserved Ejection Fraction (CASTLE-HFpEF) will provide clinical decision-making guidance and help physicians in the management of patients with HFmrEF\u002FHFpEF and AF.\n\nThe main hypothesis is that Catheter Ablation (CA) for AF is associated with improved clinical outcomes in patients with HFmrEF\u002FHFpEF and AF compared to medical AF treatment strategies on top of optimal medical HF treatment. CASTLE-HFpEF aims to study these hard clinical outcomes in a randomized cohort of patients with AF and HFmrEF\u002FHFpEF.",[156,28],"Atrial Fibrillation",[158,90,159,160,161],"A-fib","HFmrEF","AF","Catheter ablation","NOT_YET_RECRUITING","2026-06-11",{"date":165,"type":40},"2026-06-15",{"date":167,"type":22},"2026-07",{"date":169,"type":22},"2031-10",{"name":171,"class":72},"Tulane University",{"id":173,"slug":4,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":73},"100432645","NCT04913805","Matching Perfusion and Metabolic Activity in HFpEF","MPMA","Inclusion Criteria:\n\n1. NYHA Class II-III symptoms\n2. Left ventricular ejection fraction \\>= 50%\n3. Stable medical condition for at least 2 weeks, as per investigator judgment\n4. Prior or current evidence for elevated filling pressures as follows:\n\n   a. Mitral early (E)\u002Fmitral septal tissue annular (e') velocity ratio \\> 8, in the context of a septal e' velocity \\\u003C=7, in addition to one of the following: i. Large left atrium (LA volume index \\> 34 mL\u002Fm2) ii. Chronic loop diuretic use for control of symptoms iii. Elevated natriuretic peptides within the past year (e.g. NTproBNP \\> 125 pg\u002FmL in sinus rhythm or \\> 375 pg\u002FmL if in atrial fibrillation) b. Mitral E\u002Fe' ratio \\> 14 at rest or during exercise c. Elevated invasively-determined filling pressures previously (resting left ventricular end-diastolic pressure \\>= 16 mm Hg or pulmonary capillary wedge pressure \\>= 15 mmHg; or PCWP\u002FLVEDP \\>= 25 mmHg with exercise) d. Prior episode of acute heart failure requiring IV diuretics\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years old\n2. Pregnancy:\n3. Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted\n4. Uncontrolled atrial fibrillation, as defined by a resting heart rate \\> 100 beats per minute at the time of the baseline assessment\n5. Hemoglobin \\\u003C 10 g\u002FdL\n6. Subject inability\u002Funwillingness to exercise\n7. Moderate or greater left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), mild or greater mitral stenosis, severe right-sided valvular disease\n8. Known hypertrophic, infiltrative, or inflammatory cardiomyopathy\n9. Clinically significant pericardial disease, as per investigator judgment\n10. Current angina due to clinically significant epicardial coronary disease, as per investigator judgment\n11. Acute coronary syndrome or coronary intervention within the past 2 months\n12. Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension)\n13. Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease meeting Stage III or greater GOLD criteria (FEV1\\\u003C50%), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea, desaturation to \\\u003C90% on the baseline maximal effort cardiopulmonary exercise test\n14. Clinically-significant ischemia, as per investigator's judgement, on stress testing without either (1) subsequent revascularization, (2) an angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgment; (3) a follow-up 'negative' stress test, particularly when using a more specific technique (i.e., a negative perfusion imaging test following a 'positive' ECG stress test)\n15. Left ventricular ejection fraction \\\u003C 45% on a prior echocardiogram or cardiac MRI, unless the reduced LVEF occurred within the context of an uncontrolled supraventricular arrhythmia, with return of a normal ejection fraction following treatment of the arrhythmia\n16. Significant liver disease impacting synthetic function or volume control (ALT\u002FAST \\> 3x ULN, Albumin \\\u003C 3.0 g\u002FdL)\n17. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m\\^2\n18. Methemoglobin \\> 5%\n19. Serum potassium \\> 5.0 mEq\u002FL\n20. Severe right ventricular dysfunction\n21. Baseline resting seated systolic blood pressure \\> 180 mmHg or \\\u003C 100 mmHg\n22. Persistently low (\\\u003C100 mmHg) or high (\\>180 mmHg) seated blood pressure at the baseline visit\n23. Orthostatic blood pressure response to the transition from supine to standing (\\>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing)\n24. Active participation in another study that utilizes an investigational agent (observational studies\u002Fregistries allowed)\n25. Any condition that, in the opinion of the investigator, will interfere with the performance and completion of the study.",{"count":179,"type":22},53,[120],"This study will test whether pharmacologic agents that increase perfusion \\[Potassium Nitrate (KNO3)\\], with and without additional supplements that may improve mitochondrial function \\[Propionyl-L-Carnitine (PLC) and Nicotinamide Riboside (NR)\\], improve submaximal exercise endurance and skeletal muscle oxidative phosphorylation capacity (SkM OxPhos) in participants with Heart Failure with Preserved Ejection Fraction (HFpEF).",[28],"2026-06-01",{"date":185,"type":40},"2026-06-02",{"date":187,"type":40},"2021-10-11",{"date":189,"type":22},"2027-05-01",{"name":191,"class":72},"University of Pennsylvania",{"id":193,"slug":4,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":73},"100618407","NCT07331220","Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction","PADN-HFpEF","Inclusion Criteria:\n\n1\\. The subject, or their legal guardian, must have a clear understanding of the trial's design and treatment procedures. They must provide written informed consent before any trial-specific tests or procedures are conducted.\n\n2\\. Both male and female subjects age between 18 \\~ 85 years old. 3. Dyspnea on exertion (NYHA functional class II-IV) not explained by non-cardiac or ischemic etiology.\n\n4\\. LVEF \\>40% on imaging within 24 months prior to enrollment, with no clinical changes suggesting worsening systolic function.\n\n5\\. Elevated NT-proBNP or BNP levels meeting the following thresholds stratified by age and atrial fibrillation (AF) status:\n\n1. Patients WITHOUT atrial fibrillation:\n\n   1. Age \\\u003C50 years: BNP \\>100 pg\u002FmL or NT-proBNP \\>450 pg\u002FmL\n   2. Age 50-75 years: BNP \\>150 pg\u002FmL or NT-proBNP \\>900 pg\u002FmL\n   3. Age \\>75 years: BNP \\>200 pg\u002FmL or NT-proBNP \\>1800 pg\u002FmL\n2. Patients WITH atrial fibrillation:\n\n   1. BNP \\>150 pg\u002FmL or NT-proBNP \\>300 pg\u002FmL\n\n      6\\. Stable HF GDMT (no change in either types or dose) for ≥14 days prior to enrollment, including SGLT2i and spironolactone. Other medication, including angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), angiotensin receptor-neprilysin inhibitor (ARNI, sacubitril\u002Fvalsartan), beta-blockers, or calcium channel blockers (CCBs), were left at physician's discretion.\n\n      7\\. Dose changes of ACEIs, ARBs, sacubitril\u002Fvalsartan, beta-blockers, or CCBs did not exceed 100% of baseline dose (i.e., no doubling or halving).\n\n      8\\. Continuous diuretic use for ≥14 days prior to screening, with stable dose in the last 7 days.\n\n      9\\. Meet at least one of the following:\n\n   \u003C!-- -->\n\n   1. Hospitalization for decompensated HF within the past 12 months\n   2. Received intravenous loop diuretic or ultrafiltration for HF within the past 12 months\n   3. Documented resting pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) \\>15 mmHg, or exercise PCWP ≥25 mmHg, or exercise LVEDP ≥20 mmHg on right heart catheterization within the past 12 months\n   4. Echocardiographic evidence within the past 24 months of left atrial enlargement (LA anterior-posterior diameter male \\>40 mm, female \\>38 mm; LA area ≥20 cm², LA volume index ≥29 ml\u002Fm²) or left ventricular hypertrophy (interventricular septal thickness or LV posterior wall thickness ≥12 mm).\n\nExclusion Criteria:\n\n1. Hospitalization for HF within 7 days prior to screening.\n2. Participation in an interventional trial (using investigational drug or device) of a non-observational registry study within 14 days prior to screening.\n3. History of blood or bone marrow donation within 4 weeks prior to screening, or planned donation during the study.\n4. Implantation of pulmonary artery pressure monitor or pacemaker within 4 weeks prior to screening, or planned implantation during the study.\n5. Hospitalization within 30 days prior to screening for: acute ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable angina, percutaneous coronary intervention (PCI), or cardiac surgery.\n6. Cardiac resynchronization therapy (CRT) within 90 days prior to screening.\n7. Planned revascularization (PCI or CABG), major cardiac surgery (including coronary artery bypass grafting, valve replacement, ventricular assist device implantation, heart transplantation, other surgery requiring thoracotomy), transcatheter aortic valve replacement (TAVR), or CRT implantation within 90 days after screening.\n8. History of femoral or jugular vein surgery.\n9. Life expectancy \\\u003C1 year at screening.\n10. Estimated glomerular filtration rate (eGFR) \\\u003C20 ml\u002Fmin\u002F1.73 m² at screening (calculated using the modified MDRD formula).\n11. BNP \\\u003C150 pg\u002Fml and NT-proBNP \\\u003C300 pg\u002Fml at screening.\n12. Serum potassium \\>5.5 mmol\u002FL at screening.\n13. Physical examination showing volume depletion at screening or randomization.\n14. Mean supine systolic blood pressure \\\u003C100 mmHg at screening or randomization.\n15. Uncontrolled hypertension, defined as mean supine systolic blood pressure ≥160 mmHg (average of three measurements) at screening.\n16. Documented stable-state LVEF \\\u003C40% within the past 24 months.\n17. Current active malignancy (excluding non-melanoma skin cancer).\n18. HF due to specific cardiomyopathies, including: restrictive\u002Finfiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular stenosis, hypertrophic obstructive cardiomyopathy (HOCM).\n19. Chronic obstructive pulmonary disease (COPD) judged as the primary cause of dyspnea.\n20. Myocardial ischemia judged as the primary cause of dyspnea.\n21. Isolated right heart failure due to pulmonary disease.\n22. Complex congenital heart disease.\n23. History of allergic reaction to guideline-directed HF medications.\n24. Pregnant\u002Flactating women. Women of childbearing potential (WOCBP) defined as post-menarche and not permanently sterilized (hysterectomy\u002Fbilateral tubal ligation) or postmenopausal (natural amenorrhea ≥12 months without other medical cause). Sexually active WOCBP must agree to use medically accepted contraception during the study, including: \\|surgical sterilization, progestin contraceptives (oral\u002Fimplant), barrier methods (condom\u002Fdiaphragm) with spermicide, intrauterine device (IUD). Urine pregnancy test required at each visit; negative result required for continued participation.\n25. Other exclusion criteria as judged by the investigator, including but not limited to conditions that may jeopardize patient safety during study participation, factors interfering with study data interpretation, or patients unlikely to comply with study procedures\u002Frequirements.","85 Years",{"count":200,"type":22},310,[60],"To assess the impact of PADN combined with guideline-directed medical therapy (GDMT) versus a sham procedure with GDMT on clinical outcomes in heart failure (HF) patients with preserved left ventricular ejection fraction (LVEF\\>40%). Outcomes include cardiovascular death, HF-related rehospitalization, requirement for heart transplantation or need of valvular treatment or LVAD or pacemaker implantation, and worsening in outpatients (defined as requirement for intravenous therapy or diuretic intensification, including increasing the types or dose of diuretics).",[28],[205,128,206,207],"Pulmonary artery denervation","Guideline-directed medical therapy","Clinical worsening","2026-05-24",{"date":210,"type":40},"2026-05-27",{"date":212,"type":22},"2026-12-30",{"date":214,"type":22},"2028-12-30",{"name":216,"class":72},"Nanjing First Hospital, Nanjing Medical University",{"id":218,"slug":4,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":90,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":223,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":73},"100624712","NCT07413198","BOOST: Blended Onsite and Offsite Structured Exercise Training and Coaching","A Novel, Group-mediated Exercise Intervention With Remote Activity Monitoring in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)","Inclusion Criteria:\n\n* Diagnosis of heart failure with signs and symptoms of heart failure and at least one of the following: Evidence of increased LV filling pressures at rest, exercise, or other provocations \u002F Prior HF hospitalization \u002F Elevated heart Failure with Preserved Ejection Fraction (H2FPEF) score or elevated Heart Failure Association-Pre-test, Echocardiography \\& natriuretic peptide, Functional testing, Final etiology (HFA-PEFF) score\n* Left ventricular ejection fraction ≥ 50%\n* New York Heart Association (NYHA) functional class II-IV\n* Age ≥ 55 years old\n\nExclusion Criteria:\n\n* Significant change in cardiac medication or heart failure (HF) symptoms within 3 weeks prior to enrollment\n* Hospitalization or urgent care visit for HF within 4 weeks prior to enrollment\n* Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major Cardiac Vascular (CV) surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to enrolment\n* Uncontrolled hypertension\n* Recent or debilitating stroke\n* Severe pulmonary disease including chronic obstructive pulmonary disease (COPD)\n* Hemoglobin (Hgb) \\\u003C 9.5 g\u002FdL males and \\\u003C 9 g\u002FdL females within 30 days prior to enrollment\n* Patients with a history of heart transplant or Left Ventricular Assist Device (LVAD), currently on the transplant list\n* Significant, unrepaired cardiac valvular disease\n* A non-cardiac medical condition with an estimated life expectancy of \\\u003C 12 months\n* Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis)\n* Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter\n* A treadmill exercise test revealing: ischemia; chest pain or leg claudication; exercise Systolic Blood Pressure \\> 240 mmHg, Diastolic Blood Pressure \\> 110 mmHg; unstable hemodynamics or rhythm; or unwilling or unable to complete adequate exercise test\n* Already engaging in regular moderate to vigorous exercise conditioning defined as \\>30 minutes per day, ≥twice per week consistently during the previous 6 weeks\n* Any condition that in the judgement of the investigator precludes participation in study or study procedures such as significant dementia, mobility impairment, uncontrolled psychiatric disease, etc.\n* Inability to meet the expectations of the intervention (i.e., excessive distance from facility, work conflict with intervention)","55 Years",{"count":225,"type":22},14,[60],"Heart failure with preserved ejection fraction (HFpEF) represents a major public health burden that is both growing rapidly and has few effective therapies. Supervised exercise training (SET) is one of the few effective therapies for older patients with HFpEF, but is currently constrained by cost, resource limitations, and sub-optimal short and long-term clinical response. The objective is to develop and test novel strategies to augment the therapy of exercise training to optimize response and resource utilization in older patients with HFpEF.",[28],[91,230,231],"Supervised exercise training","Group-based exercise","2026-05-20",{"date":234,"type":40},"2026-05-26",{"date":236,"type":40},"2026-05-05",{"date":238,"type":22},"2027-03",{"name":71,"class":72},{"id":241,"slug":4,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":246,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":73},"100613678","NCT07269717","A Phase II Clinical Trial of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial on the Efficacy and Safety of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction","Inclusion Criteria:\n\n1. Age ≥ 40 years at screening, regardless of gender;\n2. Body mass index \\\u003C 35 kg\u002Fm²;\n3. Diagnosed with chronic heart failure before screening, and meeting relevant diagnostic criteria during the screening period: (1) Transthoracic echocardiography (TTE) at screening showing a resting left ventricular ejection fraction (LVEF) ≥ 60%; (2) Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) during the screening period; (3) Echocardiography showing structural or functional abnormalities of the heart, etc.;\n4. New York Heart Association (NYHA) classification of II or III at screening;\n5. KCCQ-CSS score between ≥25 and ≤75 at screening;\n6. Resting oxygen saturation \\>90% without supplemental oxygen at screening;\n7. Female participants of childbearing potential must have a negative serum pregnancy test before the first dose and must not be breastfeeding during the study. Female participants of childbearing potential and male participants whose partners are women of childbearing potential must agree to avoid donating sperm\u002Feggs from the time of signing the informed consent until three months after the last dose of the study drug and comply with relevant contraceptive requirements;\n8. Understand the study procedures and methods, voluntarily participate in this trial, and provide written informed consent.\n\nExclusion Criteria:\n\n1. Previously diagnosed or found during screening with hypertrophic cardiomyopathy (HCM), or having infiltrative\u002Fgenetic\u002Fstorage diseases that cause heart failure with preserved ejection fraction (HFpEF)\u002Fmyocardial hypertrophy (such as amyloidosis, Fabry disease, Noonan syndrome with left ventricular hypertrophy), or complete M protein or monoclonal light chain (such as κ or λ) detected in serum protein electrophoresis and serum immunofixation electrophoresis during screening (researchers may deem not applicable if amyloidosis\u002Fmultiple myeloma are excluded);\n2. Previously diagnosed or found during screening with hyperthyroidism;\n3. At any time in their clinical history, previously experienced left ventricular systolic dysfunction (LVEF \\\u003C45%);\n4. History of syncope or sustained ventricular tachycardia within 6 months prior to screening;\n5. Previously experienced cardiac arrest with resuscitation at any time or received ICD therapy for life-threatening ventricular arrhythmia within 6 months prior to screening;\n6. Previously diagnosed or found during screening with atrial fibrillation;\n7. Coronary artery disease (stenosis \\>70% in one or more coronary arteries) or myocardial infarction: newly developed within 6 months prior to screening, or occurred more than 6 months prior without completed revascularization (such as percutaneous coronary intervention or coronary artery bypass grafting);\n8. Moderate to severe aortic stenosis, hemodynamically significant mitral stenosis, or severe mitral\u002Ftricuspid regurgitation at screening (as determined by the investigator);\n9. Severe chronic obstructive pulmonary disease (COPD) or other pulmonary diseases requiring home oxygen therapy, chronic nebulization\u002Foral steroid treatment, or hospitalization due to pulmonary decompensation in the past 12 months;\n10. Acute respiratory infection at screening;\n11. Required intravenous diuretics, inotropes, vasodilators, or left ventricular assist device therapy for acute decompensated heart failure within 30 days prior to screening;\n12. Clinically significant history of malignancy within the past 5 years (excluding cancers that have been confirmed cured or in remission for ≥5 years, basal or squamous cell skin cancer that was radically excised within 5 years, carcinoma in situ of the cervix, and excised colon polyps);\n13. Electrocardiogram abnormalities posing safety risks at screening (as determined by the investigator, such as second-degree type II AV block, complete AV block, symptomatic ventricular arrhythmias, torsades de pointes, etc.);\n14. Any clinically significant abnormal screening laboratory values during screening deemed unsuitable for enrollment by the investigator;\n15. Positive result in any infectious disease screening during screening, including hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody (or AIDS virus antibody or P24 antigen);\n16. Inability to complete the six-minute walk test during screening (e.g., due to leg fractures, post-stroke mobility impairment);\n17. Patients who received β-blockers, diltiazem, or verapamil prior to screening but were not on a stable dose for more than 4 weeks before randomization, or are expected not to maintain the same medication regimen during the trial;\n18. Subjects who received heart failure medication treatment (diuretics, sodium-glucose co-transporter 2 inhibitors \\[SGLT2i\\], angiotensin receptor-neprilysin inhibitors \\[ARNI\\], mineralocorticoid receptor antagonists \\[MRA\\], angiotensin-converting enzyme inhibitors \\[ACEI\\], angiotensin II receptor blockers \\[ARB\\], glucagon-like peptide-1 \\[GLP-1\\] or GLP-1\u002Fglucose-dependent insulinotropic polypeptide \\[GIP\\]) prior to screening but have not been on a stable dose for more than 4 weeks before randomization, or are expected to be unable to maintain the same medication regimen during the trial;\n19. Subjects who used a myosin inhibitor within a period shorter than 5 half-lives before the trial drug administration;\n20. Subjects who participated in any drug or medical device clinical trial within 3 months prior to screening (participation in a clinical trial is defined as the subject having received the trial drug or medical device treatment);\n21. Other conditions deemed by the investigator that make the subject unsuitable for participation in the trial, such as conditions that may increase trial risk, affect the subject's protocol compliance, or impact the subject's ability to complete the trial due to physiological or psychological diseases or conditions.","40 Years",{"count":248,"type":22},48,[120],"This study aims to evaluate the safety and tolerability of HRS-1893 in subjects with heart failure with preserved ejection fraction.",[28],"2026-05-08",{"date":254,"type":40},"2026-05-11",{"date":256,"type":40},"2026-03-30",{"date":258,"type":22},"2027-05",{"name":260,"class":47},"Shandong Suncadia Medicine Co., Ltd.",{"id":262,"slug":4,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":267,"sex":17,"minAge":223,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":73},"100494861","NCT05723679","Targeting Breathing Limitations to Improve Functional Outcomes in HFpEF","Targeting Breathing Limitations to Improve Functional Outcomes in Heart Failure With Preserved Ejection Fraction (HFpEF)","Inclusion Criteria:\n\n* signs and symptoms of heart failure\n* an ejection fraction \\> 0.50;\n* objective evidence of diastolic dysfunction. elevated biomarkers (NT-proBNP \\>300 ng\u002Fdl) or HF hospitalization\n* healthy volunteers\n\nExclusion Criteria:\n\n* age \\\u003C 55 years\n* BMI \\> 50 kg\u002Fm2\n* Atrial fibrillation with poorly controlled heart rate\n* phosphodiesterase type 5 (PDE5) inhibitor use\n* severe valvular disease\n* severe Chronic obstructive pulmonary disease (COPD)\n* Chronic kidney disease (CKD) 4 or higher\n* any restriction of ambulation and mobility.",true,"90 Years",{"count":270,"type":22},78,[60],"The overall purpose of this study is to investigate whether pulmonary limitations that increase the oxygen (O2) cost of breathing impact dyspnea on exertion (DOE) and peak exercise capacity in patients with HFpEF and obesity. As per investigator's hypothesis, obesity is likely a significant contributor to DOE and exercise intolerance in patients with HFpEF.",[28,30],[275,276,90,277,278],"exertional dyspnea","exercise intolerance","breathing limitations","cardiopulmonary physiology","2026-05-01",{"date":281,"type":40},"2026-05-07",{"date":283,"type":40},"2023-07-01",{"date":285,"type":22},"2029-06-30",{"name":287,"class":72},"University of Texas Southwestern Medical Center",{"id":289,"slug":4,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":267,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":73},"100566252","NCT06652763","Manganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction","MEMRI in HFpEF","Inclusion Criteria:\n\n* Capacity to provide informed consent\n* Symptoms (e.g. breathlessness, orthopnoea, ankle swelling, fatigue), signs (e.g. elevated jugular venous pressure, peripheral oedema, third heart sound) or established diagnosis of HF with LV ejection fraction ≥ 50%, or\n* Meets HFpEF diagnostic criteria in accordance with the HFA-PEFF diagnostic algorithm form the Heart Failure Association of the European Society of Cardiology, in which a score ≥5 points confirms diagnosis of HFpEF\n\nExclusion Criteria:\n\n* Known diagnosis of Type 1 Diabetes\n* Pregnancy or breast-feeding or females of child bearing age without a negative pregnancy test\n* Receiving an investigational drug or device within 30 days prior to participating in the study\n* Decompensated heart failure or pulmonary oedema\n* History of prolonged corrected QT interval or torsades de pointes\n* Second- or third-degree atrioventricular block\n* Abnormal liver function tests (\\> 3x upper limit of normal) or history of liver disease\n* Baseline eGFR \\\u003C 30mL\u002Fmin\u002F1.73m2\n* Any contraindications to MRI including implanted devices\u002Fpacemakers\n* Severe native valve disease, restrictive cardiomyopathy, constrictive pericarditis or hypertrophic cardiomyopathy, myocarditis or takotsubo cardiomyopathy.\n* Recent myocardial infarction within the previous 3 months\n* Known diagnosis of pheochromocytoma",{"count":295,"type":22},60,"OBSERVATIONAL","Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart cannot fill with blood effectively. As a result, people with HFpEF suffer fatigue, breathlessness, and develop swollen limbs. The condition often requires multiple admissions to hospital and is associated with a marked loss of lifespan.\n\nDespite being so common, very little is known about why people develop HFpEF and there are hardly any known treatments. Type 2 diabetes (T2D) is a major risk factor for HFpEF, and people with both HFpEF and diabetes are at a heightened risk of hospitalisation and premature death. It is unclear why the combination of diabetes and HFpEF is particularly harmful. This may be related to the hearts of people with type 2 diabetes being unable to take up the mineral calcium properly, as well as due to their hearts being less energy efficient. Both of these are vital to heart muscle pumping and filling, but until recently it has not been possible to assess these in humans.\n\nNew advances in heart MRI scans, with dedicated scanner techniques and dyes (manganese contrast), now allow extremely detailed pictures of heart structure, function, calcium uptake and energy efficiency, all during the same scan. The investigators will enlist 40 volunteers with HFpEF (20 with T2D and 20 without T2D), and up to 20 healthy volunteers, to undergo a heart MRI scan with manganese contrast to assess calcium uptake and energy efficiency. This will allow the comparison of people with HFpEF with and without T2D, to see how their hearts are different to healthy volunteers.",[28,299],"Type 2 Diabetes","2026-04-29",{"date":302,"type":40},"2026-04-30",{"date":304,"type":40},"2024-10-10",{"date":306,"type":22},"2036-02",{"name":142,"class":72},{"id":309,"slug":4,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":246,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":4},"100635588","NCT07554638","Incretin Therapies in Obesity-related HFpEF","Identifying Therapeutic Mechanisms for Incretin-Based Treatment in Obesity-Related Heart Failure With Preserved Ejection Fraction (HFpEF)","Inclusion Criteria:\n\n* Diagnosis of heart failure (HF) per the ACC\u002FAHA guidelines with NYHA class II-III symptoms\n* Left ventricular ejection fraction \\>= 45% within 6 months of recruitment\n* At least one of the following: elevated N-terminal pro- B-type natriuretic peptide (NT-proBNP) \\>=200 pg\u002Fml (\\>=600 pg\u002Fml with concurrent atrial fibrillation), evidence of structural heart disease (left atrial (LA) enlargement with LA volume index \\>29 mL\u002Fm2 or LA diameter \\>=40 mm in males\u002F\\>38= mm in females), elevated filling pressures (resting wedge \\>15 mmHg or exercise wedge \\>25 mmHg, lateral E\u002Fe' ratio \\>12 or septal E\u002Fe' \\> 15)\n* Body mass index (BMI) \\>30 kg\u002Fm2\n* Stable doses of HF medications within 4 weeks of screening with optimal volume control in the opinion of the investigator.\n\nExclusion Criteria:\n\n* Acute decompensated HF within 4 weeks of screening\n* Major cardiovascular event within 90 days of screening (myocardial infarction, stroke)\n* Alternate cause of HFpEF such as cardiac amyloidosis, infiltrative cardiomyopathy, hypertrophic cardiomyopathy, severe valvular disease\n* Estimated glomerular fibrilation rate (EGFR) \\\u003C15 ml\u002Fmin\u002F1.73m2 or dialysis dependence\n* Poorly controlled diabetes (A1c \\> 9.5%) OR any type 1 diabetes mellitis\n* History of acute or chronic pancreatitis\n* Personal or family history of multiple endocrine neoplasia (MEN) or medullary thyroid cancer\n* Clinically significant gastric emptying abnormality\n* Medical comorbidities that limit survival\n* Inability to comply with the study protocol\n* Pregnancy",{"count":315,"type":22},50,[317],"PHASE4","The central hypothesis to be tested is that patients with obesity and heart failure with preserved ejection fraction (HFpEF) prescribed tirzepatide will demonstrate reductions in measured plasma volume. In conjunction with state-of-the-art body composition analysis and measures of adipokines, this will establish an important mechanism of clinical benefit and inform disease pathophysiology. To accomplish this, this study will perform a 15-month prospective cohort study in 50 patients with obesity and HFpEF who clinically qualify for treatment with tirzepatide. The investigators will serially measure plasma volume and body composition with quantitative magnetic resonance to determine changes over time with tirzepatide treatment.",[123,28,30],"2026-04-28",{"date":322,"type":40},"2026-05-04",{"date":324,"type":22},"2026-06",{"date":326,"type":22},"2030-04",{"name":328,"class":72},"Columbia University",{"id":330,"slug":4,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":349},"100503782","NCT05839730","Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction","FIRE-HFpEF","Inclusion Criteria:\n\n* Diagnosis of Heart Failure, Left Ventricular Ejection Fraction (LVEF) ≥ 55% (this and other measurements must be made within the last year).\n* New York Heart Association (NYHA) Functional Class I-III\n* Stable on guideline-directed medical therapy (GDMT) heart failure medications as determined by the investigator, for at least 1 month, with the exception of loop diuretic therapy. GDMT should be in accordance with current American Heart Association (AHA)\u002FAmerican College of Cardiology (ACC)\u002FHeart Failure Society of America (HFSA) Guidelines and include consideration of Sodium\u002Fglucose cotransporter-2 inhibitors (SGLT2i) therapy.\n* V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL\u002Fm\\^2.\n* Concentric remodeling or concentric hypertrophy defined as at least one of the following criteria:\n\n  * Left ventricular (LV) posterior or lateral wall thickness \\> 11mm\n  * Relative wall thickness (RWT) \\> 0.42\n  * Male and LV mass indexed to BSA ≥115 g\u002Fm2\n  * Male and LV mass indexed to height ≥ 49.2 g\u002Fm2.7\n  * Female and LV mass indexed to BSA ≥ 95 g\u002Fm2\n  * Female and LV mass indexed to height ≥ 46.7 g\u002Fm2.7\n\nExclusion Criteria:\n\n* Unable or unwilling to undergo contrast MRI.\n* Class I indication for permanent pacing, except for symptomatic chronotropic incompetence\n* Current permanent or persistent Atrial fibrillation (A-fib)\n* Structural heart disease requiring intervention\n* Aortic valve replacement procedure less than 12 months prior to enrollment\n* Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy\n* Severe aortic or mitral valve disease, defined as severe regurgitation or a valve area \\\u003C 1cm\\^2\n* Exertional angina\n* Severe pulmonary disease including severe Chronic obstructive pulmonary disease (COPD) (i.e., requiring home oxygen, chronic nebulizer therapy, or chronic oral steroid therapy or hospitalized for pulmonary decompensation within 12 months)\n* Estimated glomerular filtration rate (eGFR) \\\u003C 25 ml\u002Fmin\u002F1.73m\\^2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula\n* Uncontrolled blood pressure, defined as systolic pressure outside the range of 100 to 160 mmHg despite anti-hypertensive medication.",{"count":109,"type":22},[60],"FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects.",[28,339],"Concentric Hypertrophy","2026-04-23",{"date":342,"type":40},"2026-04-27",{"date":344,"type":40},"2024-09-11",{"date":346,"type":22},"2027-07",{"name":348,"class":47},"Medtronic Cardiac Rhythm and Heart Failure",8,{"id":351,"slug":4,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":267,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":366,"locationsCount":73},"100599324","NCT07083011","A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure","A Three-Arm, Observational, Pilot Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure","HFpEF Group Inclusion:\n\n* Patients aged ≥ 30 years old with exertional dyspnea (NYHA II and III) and LVEF ≥50%\n* BMI ≥ 30\n* New diagnosis of HFpEF based on RHC at baseline (elevated PCWP at rest and\u002For during exercise)\n\nHFpEF Group Exclusion:\n\n* Primary cardiomyopathy or pericardial disease or ≥ moderate valvular disease\n* Dyspnea due to lung disease or CAD\n* Severe anemia, liver, or renal disease\n* Active cancer\n* Systemic active inflammatory or autoimmune disease (e.g. rheumatoid arthritis, SLE, etc.)\n* Recent hospitalization (\\\u003C 30 days) or coronary revascularization (\\\u003C 90 days)\n* Patients already taking SGLT2i and\u002For GLP-1A\n* Pregnant or breastfeeding\n* Inability to tolerate supine position for the PET\u002FCT or CMR scans.\n* Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)\n* Known gadolinium allergy\n* Presence of implantable cardiac pacemaker or defibrillator or mechanical valve.\n\nCardiac Sarcoid Group Inclusion:\n\n* Ambulatory patients aged ≥ 18 years old\n* New referrals to the Sarcoid Clinic with a confirmed but untreated diagnosis of definite or probable CS based on 2014 HRS consensus (see Table 2)\n* With a positive cardiac 18F-FDG PET scan within 30 days.\n\nCardiac Sarcoid Group Exclusion:\n\n* Already on immunosuppressive therapy\n* Pregnant or breastfeeding\n* Severe liver or renal disease (estimated GFR \\\u003C 30 or dialysis-dependent)\n* Recent coronary revascularization (\\\u003C 90 days)\n* Active cancer\n* Known gadolinium allergy\n* Inability to tolerate supine position for the PET\u002FCT or CMR scans.\n* Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)\n* Presence of implantable cardiac pacemaker or defibrillator or mechanical valve.\n\nHealthy Controls Group Inclusion:\n\n* Adults ≥ 30 years old\n* No major chronic disease (cardiopulmonary, inflammatory, autoimmune, cancer, renal or liver impairment, etc.)\n* No intake of relevant medication, defined as regular intake of at least one of the following: anticoagulants, antiplatelets, antihypertensive \u002F diuretics, antidiabetics, antiarrhythmic, immunosuppressants, chemotherapy, antibiotics\u002Fantivirals\u002Fantifungals\n\nHealthy Controls Group Exclusion:\n\n* BMI ≥ 30\n* Pregnant or breastfeeding\n* Known gadolinium allergy\n* Inability to tolerate supine position for the PET\u002FCT or CMR scans.\n* Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)",{"count":357,"type":22},35,[120],"The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)",[28],"2026-04-22",{"date":342,"type":40},{"date":364,"type":40},"2025-11-01",{"date":346,"type":22},{"name":367,"class":72},"Mayo Clinic",{"id":369,"slug":4,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":73},"100540123","NCT06312748","Novel Approaches for Improving Vascular Function in Veterans With HFpEF","Inclusion Criteria:\n\n* Age 18 years or older and able to give written informed consent.\n* New York Heart Association (NYHA) functional class I, II, or III.\n* Left Ventricular Ejection Fraction (LVEF) \\> 50%.\n* Plasma Brain Natriuretic Peptide (BNP) equal to or greater than 150 pg\u002FmL or NT-proBNP equal to or greater than 600 pg\u002FmL at Visit 1, or a BNP equal to or great than 100 pg\u002FmL (or NT-proBNP equal to or greater than 400 pg\u002FmL) and a hospitalization for heart failure within the last 12 months.\n\nExclusion Criteria:\n\n* History of hypersensitivity or allergy to any lipophilic statin.\n* Prior EF \\\u003C50%.\n* NYHA Class IV.\n* Patients with HFpEF secondary to significant uncorrected primary valvular disease.\n* Active liver disease or unexplained persistent elevations in serum transaminase.\n* Women who are pregnant or may become pregnant.\n* Patients currently treated with antioxidants, nitrates, PDE-5 inhibitors, or statins.",{"count":374,"type":22},90,[376],"PHASE1","This project will evaluate the impact of L-Citrulline, tetrahydrobiopterin (BH4), and atorvastatin administration on physical capacity and vascular function in Veterans with heart failure with preserved ejection fraction (HFpEF).",[28,379],"Inflammation",[381,382,90,383],"vascular health","exercise tolerance","nitric oxide","2026-04-20",{"date":340,"type":40},{"date":387,"type":40},"2021-05-19",{"date":389,"type":22},"2030-09-30",{"name":391,"class":392},"VA Office of Research and Development","FED",{"id":394,"slug":4,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":267,"sex":17,"minAge":18,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":406,"leadSponsor":408,"locationsCount":73},"100623833","NCT07401771","Exercise Cardiovascular Magnetic Resonance In Heart Failure With Preserved Ejection Fraction","Inclusion Criteria:\n\n1. Informed consent obtained\n2. Three groups will be enrolled:\n\n   1. HFpEF (cardiologist-adjudicated diagnosis as verified by PI, EF≥50%)\n   2. Non-cardiac dyspnea (patients have dyspnea but were found on invasive exercise testing not to have HFpEF).\n   3. Healthy volunteers with no history of dyspnea or effort intolerance.\n\nExclusion Criteria:\n\n1. Contraindication for low-field CMR, as indicated in MRI safety screening checklist (Research Document #1)\n2. Patient inability or unwillingness to undergo Ex-CMR\n3. Cardiac implants, mechanical or biological valve, causing artifacts that compromise the quality of data\n4. Hospitalization for heart failure in the preceding 30 days.\n5. Large R-R interval variation, caused by frequent premature ventricular contractions or non-sinus rhythms such as persistent atrial fibrillation, which, in the opinion of the investigators, compromises the quality of data acquisition, image analysis and disrupts the consistency of the cohorts\n6. Myocardial infarction or unstable angina pectoris\n7. Planned coronary, carotid, or peripheral artery revascularization\n8. Other causes of dyspnea as indicated in patients' medical history based upon the opinion of the PI, such as restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, more than moderate chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, severe anemia, or more than moderate mitral or aortic heart valve disease).","80 Years",{"count":400,"type":22},400,"The purpose of this study is to internally validate low-field Ex-CMR as a noninvasive tool for diagnosing, phenotyping, and risk stratifying HFpEF in patients with exertional dyspnea.",[28],"2026-04-15",{"date":384,"type":40},{"date":167,"type":22},{"date":407,"type":22},"2028-03",{"name":367,"class":72},{"id":410,"slug":4,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":73},"100449906","NCT05138575","SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial","SAK","Inclusion:\n\n1\\. NYHA Class II-III symptoms 2. Left ventricular ejection fraction \\>= 50% 3. Stable medical condition for at least 2 weeks, as per investigator judgment 4. Prior or current evidence for elevated filling pressures, as evidenced by at least one of the following:\n\na. Mitral early (E)\u002Fseptal tissue annular (e') velocity ratio \\> 8, in the context of a septal e' velocity \\\u003C=7 cm\u002Fs or a lateral e' \\\u003C= 10 cm\u002Fs, in addition to one of the following: i. Large left atrium (LA volume index \\> 34 mL\u002Fm2) ii. Chronic loop diuretic use for control of symptoms iii. Elevated natriuretic peptides within the past year (e.g., NTproBNP \\> 125 pg\u002FmL in sinus rhythm or \\> 375 pg\u002FmL if in atrial fibrillation) b. Mitral E\u002Fe' ratio \\> 14 at rest or during exercise c. Elevated invasively-determined filling pressures previously (resting left ventricular end-diastolic pressure \\>= 16 mm Hg or pulmonary capillary wedge pressure \\>= 15 mmHg; or PCWP\u002FLVEDP \\>= 25 mmHg with exercise) d. Prior episode of acute heart failure requiring IV diuretics\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years old\n2. Pregnancy: Women of childbearing potential will undergo a urine pregnancy test during the screening visit.\n3. Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted\n4. Uncontrolled atrial fibrillation, as defined by a resting atrial fibrillation heart rate \\> 100 beats per minute at the time of the baseline assessment\n5. Hemoglobin \\\u003C 10 g\u002FdL\n6. Subject inability\u002Funwillingness to exercise\n7. Moderate or greater left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), mild or greater mitral stenosis, severe right-sided valvular disease\n8. Known hypertrophic, infiltrative, or inflammatory cardiomyopathy\n9. Clinically significant pericardial disease, as per investigator judgment\n10. Current angina due to clinically significant epicardial coronary disease, as per investigator judgment\n11. Acute coronary syndrome or coronary intervention within the past 2 months\n12. Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension)\n13. Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease Stage III or greater GOLD criteria (FEV1\\\u003C50%), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea.\n\n    \\- Desaturation to \\\u003C90% on the baseline maximal effort cardiopulmonary exercise test will also be grounds for exclusion\n14. Clinically-significant ischemia, as per investigator's judgement, on stress testing without either (1) subsequent revascularization, (2) an angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgment; (3) a follow-up 'negative' stress test, particularly when using a more specific technique (i.e., a negative perfusion imaging test following a 'positive' ECG stress test)\n\n    \\- Exercise-induced regional wall motion abnormalities on the echocardiographic assessment during the baseline maximal effort cardiopulmonary exercise test will also be exclusionary\n15. Left ventricular ejection fraction \\\u003C 45% on a prior echocardiogram or cardiac MRI, unless the reduced LVEF occurred within the context of an uncontrolled supraventricular arrhythmia, with return of a normal ejection fraction following treatment of the arrhythmia\n16. Significant liver disease impacting synthetic function or volume control (ALT\u002FAST \\> 3x ULN, Albumin \\\u003C 3.0 g\u002FdL)\n17. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2.\n18. Methemoglobin \\> 5%\n19. Serum potassium \\> 5.0 mEq\u002FL on baseline testing\n20. Type I Diabetes\n21. History of ketoacidosis\n22. Current use of, or prior intolerance to, an SGLT2i\n23. Ongoing maintenance of a 'Ketogenic Diet' (low carbohydrate, high fat)\n24. Allergy to beets\n25. Severe right ventricular dysfunction\n26. Baseline resting seated systolic blood pressure \\> 180 mmHg or \\\u003C 100 mmHg\n27. Persistently low or high seated blood pressure or orthostatic blood pressure response to the transition from supine to standing (\\>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing, or a fall in SBP to \\\u003C 90 mmHg) at the baseline visit\n28. Active participation in another study that utilizes an investigational agent (observational studies\u002Fregistries allowed)\n29. Any condition that, in the opinion of the investigator, may interfere with the completion\u002Fperformance of the study. This may include comorbid or psychiatric conditions that may impede successful completion of the protocol, or logistical concerns (e.g., inability to travel to the exercise unit).",{"count":179,"type":22},[120],"This study will test whether pharmacologic agents that may improve mitochondrial function and energy fuel metabolism \\[Empagliflozin (Empa)\\], with and without additional supplements that increase perfusion and fatty acid oxidation \\[Potassium Nitrate (KNO3)\\], improve submaximal exercise endurance and skeletal muscle oxidative phosphorylation capacity (SkM OxPhos) in participants with Heart Failure with Preserved Ejection Fraction (HFpEF).",[28],{"date":420,"type":40},"2026-04-16",{"date":422,"type":40},"2022-01-24",{"date":424,"type":22},"2027-05-31",{"name":191,"class":72},{"id":427,"slug":4,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":267,"sex":17,"minAge":432,"maxAge":4,"enrollmentInfo":433,"targetDuration":435,"studyType":296,"phases":4,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":447},"100555830","NCT06517186","Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction","Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction (MM-HFpEF) A HeartShare Clinical Study","Inclusion Criteria:\n\n* HFpEF criteria\n\n  1. Age ≥30 years.\n  2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)\n  3. Definition of HFpEF: signs and\u002For symptoms of HF, NYHA functional class II-IV, and at least one of the following:\n\n     1. Elevated BNP (≥75 pg\u002Fml in sinus rhythm or ≥225 pg\u002Fml in atrial fibrillation\u002Fflutter) or NTproBNP (≥225 pg\u002Fml in sinus rhythm or ≥675 in atrial fibrillation\u002Fflutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center.\n     2. Prior HF hospitalization (primary reason for the hospitalization is HF with elevated natriuretic peptide levels \\[using the thresholds listed above\\], requiring IV diuresis for HF, or pulmonary edema or pulmonary vascular congestion on chest radiography).\n     3. Previously documented elevated pulmonary capillary wedge pressure (PCWP) at rest (≥15 mmHg) or during exercise (≥25 mmHg for supine exercise or PCWP\u002Fcardiac output ratio ≥2 mmHg\u002FL\u002Fmin for upright exercise).\n     4. Elevated H2FPEF score69 (≥5) or HFA-PEFF70 score (≥5).\n\nSuspected HFpEF criteria\n\n1. Age ≥30 years.\n2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)\n3. Signs and\u002For symptoms of HF, NYHA functional class II-IV and all of the following:\n\n   1. Does not meet BNP or NT-proBNP criteria for HFpEF (above)\n   2. No prior HF hospitalization meeting HF criteria (above)\n   3. No previous hemodynamic catheterization documentation of HF (as above)\n\nExclusion Criteria:\n\n* 1\\. Inadequate echo or fluoroscopic images.\n\n  2\\. Neck anatomy unfavorable for jugular venous cannulation\n\n  3\\. Therapy with direct oral anticoagulants without cessation for a period (age, renal function, and agent specific) deemed adequate to normalize coagulation according to local clinical guidelines.\n\n  4\\. Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before or of EMB\n\n  5\\. Platelet count \\\u003C 50,000\u002Fml\n\n  6\\. Active bleeding or coagulation disorder\n\n  7\\. Infection or fever\n\n  8\\. Endocarditis\n\n  9\\. Pregnancy\n\n  10\\. Intracardiac thrombus\n\n  11\\. RV Aneurysm\n\n  12\\. Clinically significant tricuspid, pulmonary or aortic valve stenosis\n\n  13\\. Tricuspid or pulmonary mechanical valve prosthesis\n\n  14\\. Left bundle branch block","30 Years",{"count":434,"type":22},180,"4 Years","The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use this information to develop new treatments for heart failure.",[32,28],"2026-04-08",{"date":440,"type":40},"2026-04-09",{"date":442,"type":40},"2024-11-08",{"date":444,"type":22},"2026-12",{"name":446,"class":72},"Northwestern University",6,{"id":449,"slug":4,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":267,"sex":17,"minAge":432,"maxAge":4,"enrollmentInfo":454,"targetDuration":435,"studyType":296,"phases":4,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":463,"locationsCount":447},"100506380","NCT05873634","HeartShare: Combining Omics, Deep Phenotyping, and Electronic Health Records for Heart Failure Subtypes and Treatment Targets","HeartShare Deep Phenotyping Study","Inclusion Criteria:\n\nHF Inclusion Criteria (HeartShare Registry)\n\n1. Age ≥30 years.\n2. Prior diagnosis of HF in the EHR (any left ventricular ejection fraction).\n\nNon-HF Group Inclusion Criteria (HeartShare Registry)\n\n1. Age ≥30 years.\n2. No known prior diagnosis of HF or use of loop diuretics.\n3. No known prior history of BNP \\>100 pg\u002Fml or NTproBNP \\>300 pg\u002Fml, if prior laboratory tests are available in the EHR.\n\nHFpEF Inclusion Criteria (HeartShare Deep Phenotyping Cohort)\n\n1. Age ≥30 years.\n2. Left ventricular ejection fraction ≥50% measured by echocardiography.\n3. Definition of HFpEF: signs and symptoms of HF, NYHA functional class II-IV, and at least one of the following:\n\n   1. Elevated BNP (≥75 pg\u002Fml in sinus rhythm or ≥225 pg\u002Fml in atrial fibrillation\u002Fflutter) or NTproBNP (≥225 pg\u002Fml in sinus rhythm or ≥675 in atrial fibrillation\u002Fflutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center.\n   2. Prior HF hospitalization (primary reason for the hospitalization is HF with elevated natriuretic peptide levels \\[using the thresholds listed above\\], requiring IV diuresis for HF, or pulmonary edema or pulmonary vascular congestion on chest radiography).\n   3. Elevated pulmonary capillary wedge pressure (PCWP) at rest (≥15 mmHg) or during exercise (≥25 mmHg for supine exercise or PCWP\u002Fcardiac output ratio ≥2 mmHg\u002FL\u002Fmin for upright exercise).\n   4. Elevated H2FPEF score26 (≥5) or HFA-PEFF27 score (≥5).\n\nNon-HFpEF Group Inclusion Criteria (HeartShare Deep Phenotyping Cohort)\n\n1. Age ≥30 years.\n2. Left ventricular ejection fraction ≥50% measured by echocardiography.\n3. No known prior diagnosis of HF or use of diuretics for fluid management.\n4. No known prior history of BNP ≥75 pg\u002Fml or NTproBNP ≥225 pg\u002Fml, if prior laboratory tests are available in the EHR.\n5. BNP \\\u003C75 pg\u002Fml or NTproBNP \\\u003C225 pg\u002Fml at the time of screening. Choice of BNP or NTproBNP is based on availability at each clinical center.\n\nExclusion Criteria:\n\nExclusion Criteria (HeartShare Registry) The following exclusion criteria apply to both HF and non-HF group participants, unless otherwise indicated.\n\n1. For non-HF group: any prior known left ventricular ejection fraction \\\u003C50%.\n2. Prior history of solid organ transplantation.\n3. Prior history of mechanical circulatory support.\n4. Prior history of non-cardiac cirrhosis.\n5. Inability to provide written consent to the study.\n\nExclusion Criteria (HeartShare Deep Phenotyping Cohort) The following exclusion criteria apply to both HFpEF and non-HFpEF group participants, unless otherwise indicated.\n\n1. Life expectancy estimated to be \\\u003C 1 year.\n2. Primary cardiomyopathy (including amyloid, hypertrophic cardiomyopathy, cardiac sarcoidosis, hemochromatosis, or other infiltrative cardiomyopathies) or pulmonary arterial hypertension (WHO Group I, III, or IV pulmonary hypertension).\n3. Any prior known left ventricular ejection fraction \\\u003C40%, except if this occurred only in the setting of an acute tachycardia episode (e.g., acute atrial fibrillation).\n4. Clinically significant valvular heart disease defined as:\n\n   1. Moderate to greater aortic stenosis, pulmonic stenosis, or tricuspid stenosis.\n   2. Any mitral stenosis.\n   3. Moderate or greater aortic regurgitation.\n   4. Greater than moderate mitral regurgitation.\n5. Any planned cardiac surgery or cardiac intervention in the next 3 months.\n6. Alternative primary reason for symptoms of shortness of breath and exercise intolerance in HFpEF participants in the opinion of the enrolling investigator.\n7. Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention, stroke, transient ischemic attack, or carotid intervention in the preceding 6 months prior to enrollment.\n8. Known symptomatic epicardial coronary artery disease that is not revascularized.\n9. Any non-elective hospitalization in the preceding 2 weeks.\n10. Prior history of solid organ transplantation.\n11. Prior history of chronic infection (HIV, hepatitis C, hepatitis B, tuberculosis) unless treated and not clinically active in the opinion of the enrolling investigator.\n12. Prior history of mechanical circulatory support.\n13. Prior history of non-cardiac cirrhosis.\n14. Estimated GFR \\\u003C20 ml\u002Fmin\u002F1.73m2 or currently on dialysis.\n15. Any condition that may preclude participation or adherence to the study protocol, in the opinion of the enrolling investigator.\n16. Inability to provide written consent to the study.\n17. Current acute decompensated heart failure.\n18. Currently pregnant.",{"count":455,"type":22},1000,"HeartShare is a comprehensive study of heart failure, a common and serious medical condition which occurs when the heart is unable to keep up with the demands of the body, resulting in shortness of breath, fluid retention, and fatigue. HeartShare aims to better classify heart failure into subtypes to help develop more personalized treatments for patients, with the hope that this will improve the lives of heart failure patients. To do this, HeartShare is bringing together a large amount of data (including images, such as heart ultrasounds and MRIs and molecular data from the blood, such as genetics) from previously conducted studies and electronic health records, and is gathering new data through participants enrolled in the HeartShare Deep Phenotyping Study.",[32,28],{"date":459,"type":40},"2026-04-13",{"date":461,"type":40},"2023-03-01",{"date":444,"type":22},{"name":446,"class":72},{"id":465,"slug":4,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":198,"enrollmentInfo":469,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":475,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":73},"100494556","NCT05719714","Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease","Inclusion Criteria:\n\n1. \\>18 years of age\n2. eGFR 25-60 ml\u002Fmin\u002F1,73m2 (eGFR = estimated glomerular filtration rate)\n3. On stable doses of diuretics and\u002For angiotensin converting enzyme inhibitor or angiotensin receptor blocker\n4. Evidence of subclinical heart failure with preserved ejection fraction at their pre-exercise echocardiogram (defined as meeting 3\u002F5 of the American Society of Echocardiography (ASE) criteria for diastolic dysfunction \\[septal e'\\\u003C7 cm\u002Fwc, average E\u002Fe' ratio\\>14, left atrial volume index \\>34 mL\u002Fm2, and peak TR velocity \\>2.8 m\u002Fsec\\] or absolute left ventricular longitudinal strain \\\u003C 18%, left atrial reservoir strain (LARS) \\\u003C 25% on 2d speckle tracking echocardiography), lack of augmentation of LVLS or LARS during exercise, or peak VO2 Females: ≤ 18 mL\u002Fkg\u002Fmin, peak VO2 Males: ≤ 20 mL\u002Fkg\u002Fmin on cardiopulmonary exercise testing.\n\nExclusion Criteria:\n\n1. presence or history of diabetes\n2. coronary revascularization within the last 6 months\n3. hemodynamically significant valvular disease\n4. significant lung disease requiring home oxygen\n5. angina (chest pain)\n6. non-revascularized myocardial ischemia\n7. systolic BP \\\u003C100 or \\>180 mmHg\n8. pregnancy\n9. clinical heart failure symptoms\n10. history of systemic disease processes that can cause HFpEF such as amyloidosis or sarcoidosis\n11. any musculoskeletal or chronic condition that will interfere with completion of cardiac testing\n12. active cancer\n13. immunosuppressive therapy\n14. baseline or pre-exercise echocardiogram demonstrates a reduced ejection fraction \\\u003C 50%\n15. currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy\n16. Hypersensitivity to a SGLT2i\n17. Pre-existing liver disease\n18. ALT\u002FAST\\> 3x normal (ALT = alanine aminotransferase AST = aspartate aminotransferase)\n19. history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months",{"count":295,"type":22},[376,120],"The goal of this study is to better understand the effects of a sodium-glucose transport protein 2 inhibitor, dapagliflozin, added on to standard of care on heart and lung function and circulating metabolites (substances created when our bodies break down food, drugs, or its own tissues) in patients with chronic kidney disease.",[473,28,474,32],"Chronic Kidney Diseases","Kidney Diseases",[476,477,478],"kidney","heart failure","kidney diseases","2026-04-06",{"date":459,"type":40},{"date":482,"type":40},"2024-01-16",{"date":484,"type":22},"2026-09-30",{"name":446,"class":72},{"id":487,"slug":4,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":398,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":494,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":73},"100443699","NCT05057806","SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan","Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan","Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \\\u003C50%\n* Age 18-80 years\n* BMI 23-38 kg\u002Fm2\n* Glycated hemoglobin (HbA1c) 5.5-10%\n* Blood Pressure (BP) ≤ 145\u002F85 mmHg\n* Estimated glomerular filtration rate (eGFR) ≥30 ml\u002Fmin•1.73 m2\n* Stable dose of guideline-directed medications for heart failure and Diabetes\n* Stable body weight (±4 pounds) over the last 3 months\n* Does not suffer from severe claustrophobia\n* No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)\n\nExclusion Criteria:\n\n* Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone\n* Pregnancy, lactation or plans to become pregnant\n* Allergy\u002Fsensitivity to study drugs or their ingredients\n* Cancer\n* Current drug or alcohol use or dependence\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent",{"count":493,"type":22},30,[495],"EARLY_PHASE1","The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.",[498,28],"Type2 Diabetes",[500,501],"Ketones","Cardiovascular benefit",{"date":479,"type":40},{"date":504,"type":40},"2021-01-13",{"date":506,"type":22},"2027-03-31",{"name":508,"class":72},"The University of Texas Health Science Center at San Antonio",{"id":510,"slug":4,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":515,"enrollmentInfo":516,"targetDuration":4,"studyType":23,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":530},"100563500","NCT06616974","A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)","A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)","Inclusion Criteria:\n\n1. Is a male or female of non-childbearing potential between the ages of 18 and 83 years.\n2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).\n3. Has NYHA functional class II- III heart failure.\n4. Has 6MWT distance from 100 to 450m.\n5. Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening.\n6. Is able to understand and provide documented consent for participation.\n\nExclusion Criteria:\n\n1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.\n2. Current or recent hospitalization prior to screening.\n3. Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.\n4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.\n5. Has a body mass index \\\u003C18 kg\u002Fmeter square or \\>45 kg\u002F meter square.\n6. Was previously administered TX000045, relaxin, or a relaxin fusion protein.\n7. Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.\n8. Has any of the following clinical laboratory values during screening:\n\n   1. Serum alanine aminotransferase or aspartate aminotransferase levels \\> 3 x the upper limit of normal (ULN) or total bilirubin \\> 3 x ULN;\n   2. eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2;\n   3. HbA1c (glycosylated hemoglobin) \\>9%;\n   4. Platelet count \\\u003C50,000\u002Fmillimeter cube;\n   5. Hemoglobin \\\u003C10.0g\u002FdL;\n9. History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.\n10. Is pregnant or breastfeeding.\n11. Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin.\n12. Has a history of drug or alcohol abuse.\n13. Was recently dosed in any clinical research study.","83 Years",{"count":434,"type":22},[120],"TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).",[520,28],"Pulmonary Hypertension","2026-03-26",{"date":523,"type":40},"2026-03-27",{"date":525,"type":40},"2024-09-04",{"date":527,"type":22},"2026-11-20",{"name":529,"class":47},"Tectonic Therapeutic",86,{"id":532,"slug":4,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":17,"minAge":246,"maxAge":198,"enrollmentInfo":538,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":540,"conditions":541,"keywords":543,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":73},"100489346","NCT05651919","PBMC as Biomarkers of Diabetic Cardiomyopathy","Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy","MOBI","Inclusion Criteria:\n\nInclusion criteria common to the 4 groups:\n\n* Patient attending a scheduled cardiology or endocrinology follow-up visit\n* Patient fasting for blood sampling\n* Male or female aged 40 to 85 years inclusive\n* Patient not opposing participation in this research\n* Patient agreeing to the storage of biological samples and to genetic analyses\n\nGroup 1: No-T2D +MS \u002F No-HF (control group)\n\n\\- Patient without T2D or MS and without heart failure coming to a consultation or day hospital for another reason (e.g. screening for atypical symptom, etc.)\n\nGroup 2: No-T2D +MS \u002F HFpEF or HFmrEF\n\n* Patient without T2D or MS\n* HFpEF or HFmrEF. diagnosed\n\nGroup 3: T2D+MS \u002F no-HF\n\n* Patient diagnosed with T2D+MS\n* \\- Absence of HF\n\nGroup 4: T2D +MS \u002F HFpEF or HFmrEF\n\n* Patient diagnosed with T2D and MS\n* HFpEF or HFmrEF. diagnosed\n\nExclusion Criteria:\n\nNon-inclusion criteria common to the 4 groups:\n\n* History of cardiovascular disease (valvular disease \\[greater than moderate severity\\], radiation-induced, post-cardiotoxic chemotherapy, amyloidosis, etc.) other than HFpEF or HFmrEF\n* Acute or ongoing systemic inflammatory or infectious disease\n* History of known coronary artery disease\n* Uncontrolled hypertension (\\>160\u002F100 mmHg)\n* Pregnant or breastfeeding women (based on interview)\n* Persons deprived of liberty by judicial or administrative decision\n* Persons undergoing psychiatric care\n* Patient under legal protection (guardianship or curatorship)\n* Subject participating in another interventional study with an ongoing exclusion period\n* Chronic kidney disease (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n\nGroup 1: No-T2D +MS \u002F No-HF (control group)\n\n* Presence of diabetes (whatever the type) and MS\n* Presence of heart failure or other known heart disease\n\nGroup 2: No-T2D +MS \u002F HFpEF or HFmrEF\n\n* Presence of diabetes (whatever the type) and MS\n* Left Ventricular Ejection Fraction (LVEF) on ultrasound ≤ 40%\n\nGroup 3: T2D+MS \u002F no-HF\n\n* Without diabetes or other type of diabetes than T2D\n* Presence of Heart failure (all types)\n\nGroup 4: T2D +MS \u002F HFpEF or HFmrEF\n\n* Absence of diabetes or presence of another type of diabetes than T2D\n* LVEF on ultrasound ≤ 40%",{"count":539,"type":22},175,"Type 2 diabetes (T2D), especially when associated with metabolic syndrome (MS) is at high risk to develop heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF), and the specific impact of T2D+MS in cardiac function impairment is usually known as \"diabetic cardiomyopathy\" (DC). Cardiac remodelling (ie hypertrophy) and subtle myocardial dysfunction are highly prevalent in T2D+MS but not specific enough to predict further HFpEF or HFmrEF. Also, current biomarkers can identify but do not predict HFpEF or HFmrEF in T2D patients; Furthermore, specific biomarkers are needed. Peripheral blood mononuclear cells (PBMC) obtained from a peripheral blood sample can provide insights from calcic and inflammatory pathways, and may identify more specific molecular signatures shared between T2D+MS and HFpEF.",[299,542,28,29],"Metabolic Syndrome",[544,545,546,547,548],"Type 2 diabetes","metabolic syndrome","Heart Failure with Preserved Ejection Fraction","heart failure with mildly reduced ejection fraction","PBMC","2026-03-23",{"date":523,"type":40},{"date":552,"type":40},"2023-05-23",{"date":554,"type":22},"2028-05-23",{"name":556,"class":72},"Hospices Civils de Lyon",{"id":558,"slug":4,"hasResults":11,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":11,"sex":17,"minAge":432,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":73},"100517302","NCT06015776","Purinergic Signaling and the Postmenopausal Heart","PGC-1, Purines and the Postmenopausal Heart","Inclusion Criteria:\n\n* Patients undergoing cardiac surgery under cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Refusal to participate\n* Emergency surgery\n* Pre-existing heart block\n* Preexisting atrial fibrillation\n* Redo surgery\n* Estrogen or hormone replacement therapy\n* History of chronic heart failure\n* History of major kidney disease","88 Years",{"count":565,"type":22},500,"There is an increased risk of diastolic heart failure in post menopausal women. Estrogen plays a positive role in regulating molecular pathways in heart remodeling. Such pathways may work through purinergic signaling and its downstream effects on the heart's mitochondrial metabolism and angiogenic response to stress. Loss of estrogen functionality in post menopausal women may account for the increased risk of diastolic heart failure. The investigators will explore said pathways using cardiac tissue obtained from patients undergoing cardiac surgery.",[88,28],"2026-03-18",{"date":570,"type":40},"2026-03-20",{"date":572,"type":40},"2019-07-01",{"date":574,"type":22},"2030-06",{"name":576,"class":72},"Beth Israel Deaconess Medical Center",{"id":578,"slug":4,"hasResults":11,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":198,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":593,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":4},"100609422","NCT07214376","A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease","A Randomized Placebo-procedure Controlled Trial of the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System PULmonary Artery Denervation Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease","The PULSE-LHD","Inclusion Criteria:\n\n1. Subject is ≥18 and ≤85 years of age\n2. Subject is diagnosed with chronic HF due to left-sided heart disease for at least 6 months prior to screening (regardless of LVEF), and remains symptomatic despite maximally tolerated class I GDMT for left heart failure and CRT as appropriate per US or EU guidelines according to region of enrollment\n3. Subject is clinically stable, defined as:\n\n   * No hospitalizations for heart failure for at least 1 month; no major changes in societal guideline-recommended class I oral GDMT for left heart failure for at least 1 month; no CRT or ICD implant in the prior 3 months; and no anticipated major changes in any HF-GDMT (other than possibly diuretic dose) or planned cardiac rhythm management device implantation after the procedure\n   * SBP is ≥90 and ≤160 mmHg and resting HR is ≥50 and ≤100 bpm (≤110 bpm for atrial fibrillation)\n4. PASP (RVSP) is ≥30 mmHg on the baseline TTE.\n5. Subject has New York Heart Association (NYHA) class II, III or IVa symptoms (IVa is defined as symptoms with minimal exertion or at rest, but the patient is able to ambulate and does not require continuous intravenous medications).\n6. Subject has 6MWD at baseline ranging from 100 to 450 m limited by dyspnea or fatigue and not orthopedic or other non-HF-related issues\n7. Subject has NT-proBNP ≥600 pg\u002FmL for patients with LVEF ≤40% or ≥200 pg\u002FmL for patients with LVEF \\>40% at the time of screening (a central lab will be made available for sites that cannot measure NT-proBNP)\n8. Subject is able and willing to follow all aspects of the research protocol including medication compliance and follow-up visits and testing.\n9. Subject or the subject's legally designated representative signs an IRB\u002FEC approved informed consent form prior to study participation.\n\nExclusion Criteria:\n\n1. Subject has a life expectancy of less than 1 year due to non-cardiovascular causes.\n2. Subject has known hypertrophic cardiomyopathy with either left ventricular (LV) outflow tract obstruction or systolic anterior motion (SAM) of the anterior leaflet of the mitral valve; pericardial disease; or infiltrative or active inflammatory myocardial disease, including known amyloidosis\n3. Subject has severe stenosis or regurgitation of any heart valve, moderate or severe stenosis of the aortic valve, or any degree of stenosis of the pulmonic valve\n4. Subject has symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke in the prior 30 days or any prior stroke with a permanent residual deficit with modified Rankin Scale (mRS) score ≥4\n5. Subject has any prior intracranial hemorrhage with or without a residual deficit, or any known intracranial pathology pre-disposing to bleeding (e.g. mass, AV fistula, aneurysm, etc.)\n6. Subjects with a known bleeding diathesis or who will refuse blood transfusions\n7. Subjects allergic to heparin (including heparin induced thrombocytopenia), unless bivalirudin or argatroban can be used for procedural anticoagulation\n8. Subjects with life threatening allergy to contrast dye that cannot be adequately pre-medicated, or any prior contrast-related anaphylaxis\n9. Subject has congenital heart disease other than mitral valve prolapse or a PFO\n10. Subject had coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in the prior 6 months or is anticipated to undergo CABG or PCI within 12 months after randomization.\n11. Subject has any pacemaker with an intracardiac sensing or pacing lead or wire implanted in the prior 3 months, or CardioMEMS HF System or other intracardiac pressure monitoring system, or cardiac contractility modulation system or baroreceptor activation therapy implanted within the prior 3 months, or any plans to implant any of these devices within 12 months after the procedure.\n12. Subject has undergone atrial fibrillation ablation within the prior 6 months or is anticipated to undergo atrial fibrillation ablation within 12 months after randomization.\n13. Subject has undergone heart valve surgery or transcatheter valve intervention within the prior 6 months or is anticipated to undergo heart valve surgery or transcatheter valve intervention (e.g., valve repair or replacement, valvuloplasty) within 12 months after randomization.\n14. Subject has any tricuspid or pulmonic valve implants (implanted annuloplasty rings are allowed).\n15. Subject has an inferior vena cava (IVC) filter implant.\n16. Subject has received a prior heart or heart-lung transplantation or is listed for heart or heart-lung transplantation or is anticipated to receive a ventricular assist device (VAD) implant within 6 months after randomization.\n17. Subjects with intracardiac thrombus on TTE.\n18. Subjects with pericardial effusion ≥10 mm on TTE\n19. Subject's PH is predominantly due to WHO Group 1, 3, 4, or 5. Note: Multifactorial features of PH may be present, but the predominant diagnosis must be WHO Group 2 CpcPH.\n20. Subject has been treated with any group 1 PAH-targeted drugs, including sotatercept, within the prior month or is planned to receive such therapy after randomization.\n21. Subject is anticipated to undergo any surgery within 6 months after randomization (other than minor surgeries requiring only local anesthesia).\n22. Subject has severe renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2 by the CKD-EPI formula, or on dialysis).\n23. Subject has severe liver insufficiency (Child-Pugh classification C).\n24. Subject has platelet count \\\u003C100 × 109\u002FL.\n25. Subject has systemic inflammatory or other disease requiring long-term use of oral glucocorticoids or immunosuppressants.\n26. Subject has active infection requiring oral or intravenous antibiotics.\n27. Subject has a body mass index (BMI) \\>45 kg\u002Fm².\n28. Subjects with severe respiratory disease, defined as any disorder of the respiratory system with diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C40% AND total lung capacity (TLC) \\\u003C60% AND forced expiratory volume in one second (FEV1) \\\u003C70% by plethysmography; OR who require ambulatory or long-term oxygen therapy\n29. Subject has known severe untreated sleep apnea. Note: Subjects with sleep apnea treated with CPAP\u002FBiPAP for at least the prior 3 months are not excluded.\n30. Subjects with pulmonary embolism or deep vein thrombosis in the prior 6 months.\n31. Subject is a pregnant or breastfeeding woman, or a woman planning to become pregnant within one year. Women of child-bearing potential must have a negative pregnancy test within 1 week of randomization.\n32. Subject is participating in another clinical trial of an investigational drug or device that has not reached its primary endpoint.\n33. Subject has severe cachexia\u002Ffrailty, substance abuse, or any other condition that the investigator believes may affect the subject's ability to comply with or complete all the study requirements including follow-up visits.\n34. Subject is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, children, impoverished persons, persons in prisons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations may also include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.",{"count":585,"type":22},750,[60],"The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.)\n\nParticipants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.",[520,589,590,591,592,32,28,86],"Heart Failure With Reduced Ejection Fraction","Hypertension","Vascular Diseases","Cardiovascular Diseases",[594,595,32,596,597],"Pulmonary Artery Denervation","Pulmonary Hypertension Due to Left Heart Disease","pulmonary hypertension","left heart failure","2026-03-11",{"date":600,"type":40},"2026-03-12",{"date":602,"type":22},"2026-04-01",{"date":604,"type":22},"2031-12-31",{"name":606,"class":47},"Pulnovo Medical, Inc.",""]