Clinical trial Phase 3 Interventional Ages 18 to 70

Empagliflozin in Hypertrophic Cardiomyopathy

Run by National Institute of Cardiology, Warsaw, Poland · NCT05182658 · Data updated 2026-11-12

Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2026-09-30.

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.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment250 (estimated)
SponsorNational Institute of Cardiology, Warsaw, Poland
Academic / other
Drugs / interventionsEmpagliflozin 10 MG, Placebo
Locations2 sites (Poland)
Trial IDNCT05182658 on ClinicalTrials.gov

What this trial studies

Hypertrophic cardiomyopathy (HCM) is the most common genetic disease of the myocardium. Conventionally, the incidence of this disease was estimated at 1: 500 people, but it is probably higher and amounts to about 1: 200 cases. In Poland, this gives 76,000 to 190,000 people. HCM is asymptomatic in some people. In others, it is associated with progressive left ventricular diastolic dysfunction due to myocardial hypertrophy and fibrosis, eventually leading to systolic dysfunction and progressive heart failure. Both heart failure with preserved left ventricular ejection fraction (LVEF) and reduced LVEF are inevitably associated with impaired physical function, often affecting young, professionally and socially active individuals. An additional significant problem in patients with HCM is arrhythmias leading to an increased risk of sudden death. At present, for patients with HCM, there is no treatment available, which could inhibit the progression of the disease. The methods of treatment proposed so far, affecting the various pathogenic mechanisms of hypertrophic cardiomyopathy, have proved to be ineffective. The aim of the project is therefore to seek a therapeutic solution for a disease for which standard medicine does not yet offer satisfactory solutions. Empagliflozin is a reversible, potent and selective competitive inhibitor of sodium-glucose co-transporter-2 (SGLT2). It is the main transporter responsible for the reabsorption of glucose from the glomerular filtrate into t…

Who can join: the full rules

Show full inclusion / exclusion criteria
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 recipient or listed for heart transplant
* implanted left ventricular assist device
* Any severe (obstructive or regurgitant) valvular heart disease expected to lead to surgery during the trial in the Investigator's opinion
* Acute decompensated HF (exacerbation of chronic HF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 1 week from discharge to screening, and during screening period until randomization
* Atrial fibrillation or atrial flutter with a resting heart rate \> 110 bpm documented by ECG at screeining
* Systolic blood pressure (SBP) ≥ 180 mmHg at randomization
* Symptomatic hypotension and/or a SBP \< 100 mmHg at screeining or randomization
* Chronic pulmonary disease requiring home oxygen, oral steroid therapy or hospitalisation for exacerbation within 12 months, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension
* Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) at screening
* Haemoglobin \< 9 g/dl at screening
* Major surgery (major according to the investigator's assessment) performed within 90 days prior to screening, or scheduled major elective surgery (e.g. hip replacement ) within 90 days after screening
* Gastrointestinal (GI) surgery or GI disorder that could interfere with absorption of trial medication in the investigator's opinion
* Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix or low risk prostate cancer
* History of ketoacidosis
* Patients who must or wish to continue the intake of any drug considered likely to interfere with the safe conduct of the trial
* Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)
* Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial
* Any other clinical condition that would jeopardise patients safety while participating in this trial, or may prevent the subject from adhering to the trial protocol

Where it's running

  • Medical University of Bialystok
    Bialystok, Poland
  • National Institute of Cardiology
    Warsaw, Poland

Study contacts

  • Principal investigator: Mateusz Śpiewak, MD, PhD — National Institute of Cardiology, Department of Radiology, Magnetic Resonance Unit

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.