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Empagliflozin in Hypertrophic Cardiomyopathy

NCT05182658 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-03-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Empagliflozin 10 MG

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Medical University of Bialystok

    collaborator OTHER

  • University of Eastern Finland

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Mateusz Śpiewak, MD, PhD · National Institute of Cardiology, Department of Radiology, Magnetic Resonance Unit

  • Mariusz Kłopotowski, MD, PhD · National Institute of Cardiology, Department of Cardiology and Interventional Angiology

  • Karol Kamiński, Professor · Medical University of Bialystok, Department of Population Medicine and Lifestyle Diseases Prevention

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2026-09-30
Completion
2026-11-30

Countries

  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05182658 on ClinicalTrials.gov