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Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Sponsor: Yonsei University
Summary
This study is a prospective, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of dapagliflozin in patients with nonobstructive hypertrophic cardiomyopathy (HCM). Patients with nonobstructive HCM frequently experience exercise intolerance, heart failure symptoms, and impaired quality of life due to diastolic dysfunction and myocardial remodeling. However, effective disease-modifying treatment options remain limited. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated clinical benefits in patients with heart failure and may improve myocardial relaxation, cardiac remodeling, and exercise capacity. Approximately 440 patients with nonobstructive HCM will be randomized in a 1:1 ratio to receive dapagliflozin 10 mg once daily or matching placebo for 24 weeks. The primary objective is to evaluate the effect of dapagliflozin on exercise capacity as measured by the change in peak oxygen consumption (peak VO₂) from baseline to Week 24. Secondary objectives include evaluation of diastolic function, echocardiographic parameters, heart failure symptoms, serum biomarkers, arrhythmic burden, and cardiac magnetic resonance imaging parameters in a predefined substudy population.
Official title: Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (DAPA-HCM)
Key Details
Gender
All
Age Range
19 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2027-01-02
Completion Date
2030-04-26
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
Dapagliflozin 10mg
Dapagliflozin 10 mg film-coated tablet administered orally once daily after breakfast for 24 weeks.
Dapagliflozin Placebo
Matching placebo film-coated tablet administered orally once daily after breakfast for 24 weeks.