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Empagliflozin in Hypertrophic Cardiomyopathy

Study acronym: EMPA-REPAIR
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 12, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date: Dec 31, 2023 to Sep 30, 2026v4 Show 5 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Aug 1, 2024 to Nov 30, 2026
    • Site details revised at 2 of 2 sites
    • Study description expanded, about 3 words
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jul 31, 2023 to Dec 31, 2023
    • Site details revised at 2 of 2 sites
    v3
  3. Notable Start date: Feb 1, 2022 to Jun 1, 2022v2 Show 4 more changesShow less
    • Primary endpoint revised
    • Interventions: Empagliflozin 10 MG (Drug) to Empagliflozin 10 MG (Drug), Placebo (Drug)
    • Secondary endpoint revised
    • Study description expanded, about 2 words
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05182658
Lead Sponsor National Institute of Cardiology, Warsaw, Poland
Collaborators: Medical University of Bialystok, University of Eastern Finland, Amsterdam UMC, location VUmc
Conditions
(from sponsor)
Hypertrophic Cardiomyopathy, Heart Failure
Related terms Cardiomyopathy, Hypertrophic, Heart Failure
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov