Empagliflozin in Hypertrophic Cardiomyopathy

NCT05182658 | Active Not Recruiting Phase 3

• 1 other identifier: 2020/ABM/01/00001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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

Hypertrophic Cardiomyopathy; Heart Failure

Keywords

Hypertrophic cardiomyopathy; Heart Failue; Empagliflozin; Sodium-glucose transport protein 2 inhibitor; SGLT2 inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in peak VO2 measured in the cardiopulmonary exercise testing and Change in 23-item KCCQ-OSS.

  12 months

Secondary Outcomes (1)

• Secondary outcome: Change in peak VO2 measured in the cardiopulmonary exercise testing in patients with reduced left ventricular ejection fraction (EF <50%)

  12 months

Study Arms (2)

Empagliflozin group

ACTIVE COMPARATOR

Patients in the empagliflozin group will receive 10 mg of empagliflozin once daily for 12 months

Drug: Empagliflozin 10 MG

Control group

PLACEBO COMPARATOR

Patients in the control group will receive placebo once daily for 12 months

Drug: Placebo

Interventions

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.

Control group

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.

Also known as: Jardiance

Empagliflozin group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written, voluntary informed consent to participate in the study
• diagnosis of hypertrophic cardiomyopathy
• age ≥ 18 years

You may not qualify if:

• refusal to consent to participate in the study
• diagnosis of diabetes
• patients with hypertrophic obstructive cardiomyopathy requiring interventional treatment (maximal LVOT gradient ≥ 50 mmHg), and who are in III-IV NYHA functional class, despite of the treatment with maximal tolerated doses
• refusal to consent to participate in the study
• diagnosis of diabetes
• patients with hypertrophic obstructive cardiomyopathy requiring interventional treatment (maximal LVOT gradient ≥ 50 mmHg), and who are in III-IV NYHA functional class, despite of the treatment with maximal tolerated doses
• ICD or cardiac pacemaker (for a group of patients in whom cardiac magnetic resonance study will be performed; n=100)
• planned implantation of cardiac resynchronization therapy (CRT of CRT-D) in the following 12 months
• life expectancy below 12 months
• pregnancy (currently or planned in the following 12 months)
• breast feeding
• age below 18 years
• recurrent genito-urinary tract infections in the past or currently
• urosepsis in the history
• Impaired renal function, defined as eGFR \< 30 mL/min/1.73 m2 (CKD-EPI)cr or requiring dialysis,

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead
• Medical University of Bialystok: collaborator
• University of Eastern Finland: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (2)

Medical University of Bialystok

Bialystok, Poland

Location

National Institute of Cardiology

Warsaw, Poland

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Heart Failure

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Mateusz Śpiewak, MD, PhD

  National Institute of Cardiology, Department of Radiology, Magnetic Resonance Unit

  PRINCIPAL INVESTIGATOR

• Mariusz Kłopotowski, MD, PhD

  National Institute of Cardiology, Department of Cardiology and Interventional Angiology

  PRINCIPAL INVESTIGATOR

• Karol Kamiński, Professor

  Medical University of Bialystok, Department of Population Medicine and Lifestyle Diseases Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 10, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)