{ "data": { "asOf": "2026-10-30T22:25:24.794Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07897500", "title": "Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial", "scientificTitle": "Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (DAPA-HCM)", "status": "not_yet_recruiting", "studyType": "interventional", "phase": [ "PHASE4" ], "conditions": [ "Nonobstructive Hypertrophic Cardiomyopathy" ], "interventions": [ { "name": "Dapagliflozin 10mg", "type": "DRUG", "description": "Dapagliflozin 10 mg film-coated tablet administered orally once daily after breakfast for 24 weeks." }, { "name": "Dapagliflozin Placebo", "type": "DRUG", "description": "Matching placebo film-coated tablet administered orally once daily after breakfast for 24 weeks." } ], "sponsor": { "name": "Yonsei University", "type": "OTHER" }, "locations": [], "outcomes": { "other": [], "primary": [ "Change From Baseline in Peak Oxygen Consumption (Peak VO₂) at Week 24" ], "secondary": [ "Change From Baseline in Cardiopulmonary Exercise Testing Parameters at Week 24", "Change From Baseline in Echocardiographic Parameters at Week 24", "Change From Baseline in Blood Biomarkers at Week 24", "Change From Baseline in Symptoms and Health Status at Week 24", "Change From Baseline in Arrhythmic Burden on 24-Hour Ambulatory Electrocardiography at Week 24", "Change From Baseline in Cardiac Magnetic Resonance Imaging Parameters at Week 24" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. Able to understand the study protocol and provide written informed consent.\n2. Adults aged 19 to 80 years.\n3. Nondiabetic participants or participants with type 2 diabetes mellitus (HbA1c 6.5% to 10.5%).\n4. Patients with nonobstructive hypertrophic cardiomyopathy (HCM) documented by echocardiography performed within 3 months prior to screening, with no significant dynamic left ventricular outflow tract (LVOT) obstruction at rest, during the Valsalva maneuver, or with exercise provocation.\n\n * Nonobstructive HCM defined as a maximum LVOT pressure gradient \\<30 mmHg.\n * Maximum left ventricular wall thickness ≥15 mm in participants without a family history of HCM, or ≥13 mm in participants with a family history of HCM or a pathogenic HCM-associated genetic variant.\n5. Participants receiving medical therapy for HCM, including beta-blockers, non-dihydropyridine calcium channel blockers, loop diuretics, thiazide or thiazide-like diuretics, mineralocorticoid receptor antagonists, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or angiotensin receptor-neprilysin inhibitors, must have been on a stable dose for at least 2 weeks prior to randomization and be expected to remain on a stable dose throughout the study period.\n6. Women of childbearing potential who agree to use effective contraception\n\nExclusion Criteria:\n\n1. History of hypersensitivity to the investigational product.\n2. Current treatment with an SGLT2 inhibitor or use within 4 weeks prior to screening. (For participants with diabetes mellitus, use of glucose-lowering medications other than SGLT2 inhibitors is permitted.)\n3. Inability to perform cardiopulmonary exercise testing (CPET).\n4. End-stage renal disease requiring dialysis or chronic kidney disease with estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73 m².\n5. Presence of a cardiac implantable electronic device (CIED), except for an implantable cardioverter-defibrillator (ICD) implanted at least 3 months before informed consent.\n6. Current pregnancy or breastfeeding.\n7. AST or ALT \\>3 times the upper limit of normal, history of hepatic encephalopathy, esophageal varices, or portocaval shunt surgery.\n8. Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg) or severe hypotension (systolic blood pressure \\<90 mmHg).\n9. Severe aortic stenosis or mitral stenosis with a potential need for surgical intervention during the study period.\n10. Candidates for heart transplantation or recipients of a previous heart transplantation.\n11. Conditions that may confound the assessment of heart failure symptoms, including severe anemia (hemoglobin \\<7 g/dL), uncontrolled arrhythmias, severe pulmonary disease, or other conditions judged by the investigator to interfere with study assessments.\n12. Active malignancy receiving chemotherapy, radiation therapy, or surgical treatment, or life expectancy of less than 1 year.\n13. Untreated alcohol abuse or substance abuse.\n14. Participation in another investigational drug or medical device study, or participation in such a study within 30 days prior to screening.\n15. Type 1 diabetes mellitus or history of diabetic ketoacidosis.\n16. New York Heart Association (NYHA) Class IV.\n17. Hereditary intolerance to lactose anhydrous, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.", "maximumAge": "80 Years", "minimumAge": "19 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 440 }, "startDate": "2027-01-02", "completionDate": "2030-04-26", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2026-10-27T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07897500" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07897500", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07897500", "sourceUrl": "https://clinicaltrials.gov/study/NCT07897500", "sourceStatus": "NOT_YET_RECRUITING", "retrievedAt": "2026-10-28T04:32:12.780Z", "payloadSha256": "19fe58a729cd3184b636e6a15cbd9e3a54e9194e98624f180fc95c0664ec8f5f", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07897500", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07897500", "verifyAt": "https://clinicaltrials.gov/study/NCT07897500", "retrievedAt": "2026-10-28T04:32:12.780Z", "payloadSha256": "19fe58a729cd3184b636e6a15cbd9e3a54e9194e98624f180fc95c0664ec8f5f", "text": "ClinicalTrials.gov, record NCT07897500 (https://clinicaltrials.gov/study/NCT07897500), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07897500, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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