Empagliflozin in Hypertrophic Cardiomyopathy

Sponsor
National Institute of Cardiology, Warsaw, Poland
Study ID
NCT05182658
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    The proposed intervention will be administration of empagliflozin at a standard dose of 10 mg daily for a period of 12 months. Patients with diagnosed diabetes will be excluded from the study. Patients (n = 250) will be randomized in a double-blind fashion to empagliflozin or placebo group.
  • Placebo — DRUG
    The proposed intervention will be administration of placebo for a period of 12 months. Patients (n = 250) will be randomized in a double-blind fashion to empagliflozin or placebo group.

Study Details

The proposed intervention will be administration of empagliflozin at a standard dose of 10 mg daily for a period of 12 months. Patients with diagnosed diabetes will be excluded from the study. Patients (n = 250) will be randomized in a double-blind fashion to empagliflozin or placebo group. The primary endpoint of the study will be the change in peak oxygen uptake (VO2 max) measured in a cardiopulmonary exercise test. VO2max is an objective indicator of physical performance and will be evaluated before and after empagliflozin or placebo treatment.

Key Dates

Start date
Jun 1, 2022
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Empagliflozin group
    Patients in the empagliflozin group will receive 10 mg of empagliflozin once daily for 12 months
  • Placebo Comparator: Control group
    Patients in the control group will receive placebo once daily for 12 months

Primary Outcome Measure

Primary Outcome: Change in peak VO2 measured in the cardiopulmonary exercise testing AND Change in 23-item Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) range from 0 to 100, with higher scores indicating better health status. [ Time Frame: 12 months ]

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