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NOT YET RECRUITING
NCT07897500
PHASE4

Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Sponsor: Yonsei University

View on ClinicalTrials.gov

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

DRUG

Dapagliflozin 10mg

Dapagliflozin 10 mg film-coated tablet administered orally once daily after breakfast for 24 weeks.

DRUG

Dapagliflozin Placebo

Matching placebo film-coated tablet administered orally once daily after breakfast for 24 weeks.