[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500264":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":40,"studyPopulation":30,"armGroups":41,"interventions":57,"overallOfficials":69,"centralContacts":74,"locations":80,"responsibleParty":96,"collaborators":30,"id":98,"slug":30,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":30,"enrollmentInfo":107,"targetDuration":30,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":82,"whyStopped":30,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Tomsk National Research Medical Center of the Russian Academy of Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Outcome (Combined)","Change of 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ) (0-100 points)+change in test distance with a 6-minute walk (6MWD - 150 meters or more) by 35 meters or more.\n\nAn increase in the number of points by 5 on the Kansas City Cardiomyopathy Questionnaire scale, increasing the distance on the 6-minute walk test by 35 meters means a better result.\n\nThe absence of changes\u002Fdecrease in the number of points on the Kansas City Cardiomyopathy Questionnaire scale, the absence of changes\u002Fdecrease in the distance in the 6-minute walking test means the worst result.","12 months",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Changing by 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ 0-100 points)","Change of 5 or more points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) (0-100 points).\n\nAn increase in the number of points by 5 on the Kansas City Cardiomyopathy Questionnaire scale means a better result.\n\nThe absence of changes\u002Fdecrease in the number of points on the Kansas City Cardiomyopathy Questionnaire scale means the worst result.","6 months",{"measure":19,"description":20,"timeFrame":17},"Changing in test distance with a 6-minute walk (6MWD 300 meters or more) of 35 meters","Change in the distance when testing a 6-minute walk by 35 meters or more. An increase the distance on the 6-minute walk test by 35 meters or more means a better result.\n\nThe absence of changes\u002Fdecrease in the distance in the 6-minute walking test means the worst result.",{"measure":22,"description":23,"timeFrame":17},"Changing functional class of chronic heart failure (CHF) by New York Heart Association (NYHA I-IV functional classes)","Reduction of the functional class of CHF according to New York Heart Association by 1point means a better result.\n\nNo changes or an increase in the functional class means a worse result.",{"measure":25,"description":26,"timeFrame":12},"Hospitalization for heart failure and death from all causes","The absence of hospitalizations for heart failure and death from all causes means a better result. Hospitalization and death from all causes means the worst result.",{"measure":28,"description":29,"timeFrame":17},"Changing by 5 or more points according to the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) (0-105 points).","A decrease of 5 or more points on the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) means a better result.\n\nThe absence of changes\u002Fincrease in the number of points on the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) means the worst result.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":37},"DOUBLE",[38,39],"PARTICIPANT","INVESTIGATOR","The prevalence of HFpEF among patients admitted to cardiology hospitals will be studied. The study will include patients with NYHA II-III who have signed an informed consent that meets the inclusion\u002Fexclusion criteria. The effectiveness of intravenous administration of iron carboxymaltose (Ferinject ® ) to correct iron deficiency and improve the clinical course of HFpEF will be evaluated. A group without iron deficiency will be recruited as a control group (n=30).",[42,48,53],{"label":43,"type":44,"description":45,"interventionNames":46},"Experimental: 1","ACTIVE_COMPARATOR","Drug: Ferinject ® (Ferric carboxymaltose)",[47],"Drug: Ferinject",{"label":49,"type":6,"description":50,"interventionNames":51},"Comparison Group: 2","Diet therapy, without drug therapy",[52],"Other: Diet therapy",{"label":54,"type":55,"description":56,"interventionNames":30},"Control Group: 3","NO_INTERVENTION","Without therapy",[58,65],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"DRUG","Ferinject","The calculation of the dose of iron carboxymaltosate (Ferinject ® preparation) for the purpose of correction of iron will be carried out on the basis of the following step-by-step approach: determination of individual iron needs, calculation and administration of iron dose, assessment of the saturation of the patient's body with iron 6 weeks after infusion.",[43],[64],"Ferric carboxymaltose",{"type":6,"name":66,"description":67,"armGroupLabels":68,"otherNames":30},"Diet therapy","Patients will receive diet therapy to correct latent iron deficiency",[49],[70],{"name":71,"affiliation":72,"role":73},"Alla A. Garganeeva, M.D.","Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences","PRINCIPAL_INVESTIGATOR",[75],{"name":76,"role":77,"phone":78,"phoneExt":30,"email":79},"Olga V. Tukish, Ph.D.","CONTACT","+79069476343","olgatukish@yandex.ru",[81],{"facility":72,"status":82,"city":83,"state":30,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"RECRUITING","Tomsk","634012","Russia","RU",{"type":88,"coordinates":89},"Point",[90,91],84.98216,56.50049,{"lat":91,"lon":90},[94],{"name":76,"role":77,"phone":95,"phoneExt":30,"email":79},"89069476343",{"type":97,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100500264",false,"NCT05793996","The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)","Study of the Prevalence of Iron Deficiency Among Hospitalized Patients With HFpEF and the Impact of Ferinject® on Indicators of Quality of Life, Functional Status in Patients With Iron Deficiency","ID-HFpEF","Inclusion Criteria:\n\n* Signed informed consent to participate in the study;\n* In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF);\n* Left ventricular ejection fraction (LVEF) ≥50%; objective signs of structural and\u002For functional disorders of the heart consistent with the presence of LV diastolic dysfunction\u002Fincreased LV filling pressure, including elevated levels of natriuretic peptide;\n* Screening ferritin below 100 µg\u002FL, or below 300 µg\u002FL when transferrin saturation (TSAT) is below 20%;\n* Screening haemoglobin (Hb) at the time of switching on ( 90-150 g\u002Fl).\n\nExclusion Criteria:\n\n* Uncontrolled arterial hypertension;\n* Аnemia not related to iron deficiency;\n* Аnemia with a hemoglobin level of less than 90 g\u002Fl;\n* Less than 1 year after acute myocardial infarction;\n* Less than 1 year after acute cerebral circulation disorder;\n* Less than 1 year after surgical interventions, including non-cardiac operations and myocardial revascularization (coronary bypass surgery, coronary artery stenting), operations for valvular pathology;\n* Chronic alcoholism (including alcoholic heart disease), mental disorders;\n* Severe hepatic (increased transaminase levels above the upper three limits of normal) and renal insufficiency (glomerular filtration rate less than 15 ml\u002Fmin\u002F1.73 m2);\n* Known active infection, clinically significant bleeding, active malignancy;\n* Severe autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.);\n* Severe bronchial asthma, COPD in the acute stage;\n* Allergic reactions to medications in the anamnesis, eczema, atopic allergic reaction;\n* Blood transfusions and taking erythropoiesis-stimulating drugs during the previous three months.","ALL","18 Years",{"count":108,"type":109},100,"ESTIMATED","INTERVENTIONAL",[112],"PHASE4","Observational cohort randomized controlled study to study the influence of correction of ID by intravenous injection of ferric carboxymaltose (Ferinject®) on quality of life indicators, functional status in a cohort of patients with HFpEF.",[115,116],"Chronic Heart Failure","Iron Deficiency, Latent",[118,119,120,60],"HFpEF","iron deficiency","ferric carboxymaltose","2026-06-23",{"date":123,"type":124},"2026-06-24","ACTUAL",{"date":126,"type":124},"2023-04-28",{"date":128,"type":109},"2026-12",{"name":5,"class":6},1]