[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529618":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":31,"id":35,"slug":20,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":20,"eligibilityCriteria":39,"healthyVolunteers":36,"sex":40,"minAge":41,"maxAge":20,"enrollmentInfo":42,"targetDuration":20,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Unblinded Intervention","EXPERIMENTAL","There is no control group in this study. Only intervention group due to phase of trial and study intentions.",[13],"Dietary Supplement: 2-HOBA",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","2-HOBA","2-HOBA supplement take three times daily for 12-weeks",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Thomas Strayer, PhD","CONTACT","615-936-0156","thomas.e.strayer@vumc.org",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","James D. West","Professor-Allergy, Pulmonary, and Critical Care Medicine",[32],{"name":33,"class":34},"National Institutes of Health (NIH)","NIH","100529618",false,"NCT06176118","Clinical Trial of 2-HOBA in Pulmonary Arterial Hypertension","Inclusion Criteria:\n\n* Adults aged 18 or older\n* Diagnosed with idiopathic, heritable, simple congenital heart defect, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.\n* Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.\n* FEV1\\> or = 60% predicted and no more than mild abnormalities on lung imaging\n* WHO Functional Class II-IV\n* Ambulatory\n\nExclusion Criteria:\n\n* Sensitivity to 2-HOBA\n* Sensitivity to aspirin or salicylates\n* Aspirin-related rhinitis or wheezing\n* Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane\u002Fwalker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity\n* Pregnancy\n* Diagnosis of PAH etiology other than idiopathic, heritable, simple congenital heart defect, or associated with drugs or toxins\n* Drug and toxin associated PAH patients with active drug use\n* Prior diagnosis of cirrhosis\n* Malignancy\n* eGFR by MDRD \\\u003C60mL\u002Fmin\n* Non-english speaking","ALL","18 Years",{"count":43,"type":44},12,"ESTIMATED","INTERVENTIONAL",[47],"PHASE2","Based on existing literature and clinical trials, 2- hydroxbenzylamine (2-HOBA) has clear impact on mechanisms that much of the international field of pulmonary hypertension (PH) research agrees are central to disease progression. The investigator's preliminary data and Phase I studies demonstrate not only a clear positive impact on reducing pulmonary vascular resistances in Group I and II PH, and both cytokine and molecular biomarkers of disease, but also indicated the potential for a substantial positive effect on heart function under load stress. In this Phase II project, investigators will test the safety and efficacy of 2-HOBA in PH patients, improving the function of the right ventricle under stress in a large animal model, and effectiveness in the context of standard-of-care in mouse models and large animals, to establish the remaining data needed to proceed to commercialization.",[50],"Pulmonary Arterial Hypertension",[52,53,54],"2-hoba","Pulmonary Hypertension","Right Ventricular","NOT_YET_RECRUITING","2026-06-15",{"date":58,"type":59},"2026-06-17","ACTUAL",{"date":61,"type":44},"2026-09-01",{"date":63,"type":44},"2027-12",{"name":5,"class":6}]