[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543024":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":39,"responsibleParty":54,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SGLT2 inhibitor group","EXPERIMENTAL","SGLT2 inhibitor group will receive Enavogliflozin (0.3mg oral tablet once daily).",[13],"Drug: SGLT2 inhibitor",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Control group will not receive any SGLT2 inhibitors during the study period.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","SGLT2 inhibitor","Enavogliflozin (0.3mg oral tablet once daily) will be administrated.",[9],[26],"SGLT2 inhibitor: Enavogliflozin (Brand names: Envlo tab)",[28],{"name":29,"affiliation":5,"role":30},"Jeong Hoon Yang, MD, PhD","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","82-2-3410-6475","jhysmc@gmail.com",{"name":37,"role":33,"phone":34,"phoneExt":18,"email":38},"David Hong, MD","hongdawi@naver.com",[40],{"facility":5,"status":18,"city":41,"state":18,"zip":42,"country":43,"countryCode":18,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Seoul","06351","South Korea",{"type":45,"coordinates":46},"Point",[47,48],126.9784,37.566,{"lat":48,"lon":47},[51,53],{"name":29,"role":33,"phone":52,"phoneExt":18,"email":35},"82-2-3410-3419",{"name":37,"role":33,"phone":52,"phoneExt":18,"email":38},{"type":30,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Jeong Hoon Yang","Professor","100543024","phase-4-the-efficacy-of-enavogliflozin-in-heart-failure-with-preserved-ejection-fraction-100543024",false,"NCT06350487","The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction","The Efficacy of Enavogliflozin on Exercise Performance and Diastolic Function in Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial","ENRICH-PEF","1\\. Inclusion Criteria:\n\n1\\) Age ≥19 2) New York Heart Association (NYHA) II-III dyspnea 3) Diagnosis of HFpEF (Exams conducted within 6 months from screening) \\[must satisfy all (1), (2), and (3)\\]\n\n1. Left ventricular ejection fraction (LVEF) ≥50%\n2. NT-proBNP ≥220 pg\u002FmL or BNP ≥80 pg\u002FmL, if in sinus rhythm NT-proBNP ≥660 pg\u002FmL or BNP ≥240 pg\u002FmL, if in atrial fibrillation\n3. Satisfying either noninvasive or invasive criteria I. Noninvasive: Echocardiography with at least one of the following criteria\n\n   * LAVI ≥34 ml\u002Fm2\n   * Lateral E\u002Fe' ≥9\n   * LVMI ≥115 g\u002Fm2 if male or ≥95 g\u002Fm2 if female\n   * LV wall thickness ≥12mm II. Invasive: LVEDP ≥16mmHg or pulmonary capillary wedge pressure(PCWP) ≥15mmHg 4) Stable\u002Fchronic ambulatory patients without hospitalization within the last 30 days due to heart failure decompensation episode 5) Patients taking heart failure medication without change for at least 3 weeks before screening\n\n     2\\. Exclusion Criteria:\n     1. Unwillingness or inability to comply with the procedures described in this protocol\n     2. The ability to walk is, in the investigator's opinion, clearly limited by joint disease or other locomotor problems or lung diseases rather than by cardiorespiratory fitness\n     3. NYHA IV dyspnea\n     4. Type 1 diabetes mellitus\n     5. Estimated glomerular filtration rate (eGFR) \\\u003C60 ml\u002Fmin\u002F1.73m2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula)\n     6. Anemia (Hb \\\u003C7g\u002FdL)\n     7. Severe hepatic impairment (Child-Pugh class C)\n     8. Acute myocardial infarction or unstable angina within 30 days before inclusion or planned coronary revascularization at the time of inclusion\n     9. Significant left-sided valvular heart disease (moderate to severe stenosis and severe regurgitation)\n     10. Heart failure due to any of the following: infiltrative cardiomyopathy (amyloidosis, sarcoidosis), active myocarditis, constrictive pericarditis, hypertrophic cardiomyopathy\n     11. Symptomatic hypotension (systolic blood pressure \\\u003C90mmHg)\n     12. Severe chronic obstructive pulmonary disease (postbronchodilator forced expiratory volume in 1 second (FEV1)\u002Fforced vital capacity(FVC) \\\u003C70% and FEV1 \\\u003C50%)\n     13. Treated with sodium-glucose cotransporter-2 inhibitors (SGLT2i) within 30 days before inclusion\n     14. History of diabetic ketoacidosis while in treatment with SGLT2i\n     15. Recurrent genitourinary tract infections\n     16. History of Hypersensitivity reaction to SGLT2i\n     17. Non-cardiac co-morbid conditions are present with life expectancy \\\u003C2 year or that may result in protocol non-compliance (per site investigator's medical judgment)\n     18. Female patients who are currently or planning to become pregnant\n     19. Female patients who are lactating\n     20. Patients participating in other clinical trials","ALL","19 Years",{"count":68,"type":69},154,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","The aim of prospective, open label, single center, randomized controlled trial is to investigate the efficacy of enavogliflozin on exercise performance, diastolic dysfunction, and quality of life in patients with heart failure with preserved ejection fraction (HFpEF).",[75],"Heart Failure, Preserved Ejection Fraction",[77,78,79],"Heart failure with preserved ejection fraction","Sodium glucose cotransporter 2 inhibitors","Exercise performance","NOT_YET_RECRUITING","2024-04-05",{"date":83,"type":84},"2024-04-08","ACTUAL",{"date":86,"type":69},"2024-05-01",{"date":88,"type":69},"2026-06-30",{"name":5,"class":6},1]