Empagliflozin in Hypertrophic Cardiomyopathy (NCT05182658) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Empagliflozin in Hypertrophic Cardiomyopathy
Poland250 participantsStarted 2022-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* written, voluntary informed consent to participate in the study
* diagnosis of hypertrophic cardiomyopathy
* age ≥ 18 years
Exclusion Criteria:
* 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,
* other contraindications to the use of empagliflozin
* musculo-skeletal or neurologic diseases that make it unable to perform cardiopulmonary exercise testing
* heart transplant recipi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: 12 months
Trial details
NCT IDNCT05182658
SponsorNational Institute of Cardiology, Warsaw, Poland