NCT07897500|Not Yet RecruitingPhase 4DMC
Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
DAPA-HCM
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Sponsor study identifier
interventional
440
0 countries
N/A
Study Start
January 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 26, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 26, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2026
Actual (reported)October 27, 2026
Actual (reported)January 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 26, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change From Baseline in Peak Oxygen Consumption (Peak VO₂) at Week 24
Exercise capacity will be assessed by cardiopulmonary exercise testing (CPET). The primary endpoint is the change from baseline to Week 24 in peak oxygen consumption (peak VO₂, mL/kg/min).
Baseline and Week 24
Change From Baseline in Cardiopulmonary Exercise Testing Parameters at Week 24
Baseline and Week 24
Change From Baseline in Echocardiographic Parameters at Week 24
Baseline and Week 24
Change From Baseline in Blood Biomarkers at Week 24
Baseline and Week 24
Change From Baseline in Symptoms and Health Status at Week 24
Baseline and Week 24
Change From Baseline in Arrhythmic Burden on 24-Hour Ambulatory Electrocardiography at Week 24
Baseline and Week 24
Participants randomized to the experimental arm will receive dapagliflozin 10 mg orally once daily after breakfast for 24 weeks in addition to standard medical therapy for nonobstructive hypertrophic cardiomyopathy.
Participants randomized to the control arm will receive matching placebo orally once daily after breakfast for 24 weeks in addition to standard medical therapy for nonobstructive hypertrophic cardiomyopathy.
Dapagliflozin 10 mg film-coated tablet administered orally once daily after breakfast for 24 weeks.
Matching placebo film-coated tablet administered orally once daily after breakfast for 24 weeks.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Control intervention
Dapagliflozin Placebo
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordFirst Submitted
October 11, 2026
First Posted
October 27, 2026
Study Start
January 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 1, 2029
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 26, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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