Can a diabetes drug boost heart function in non-diabetic patients?
NCT ID NCT05182658
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether empagliflozin, a drug typically used for diabetes, can help people with hypertrophic cardiomyopathy (a thickened heart muscle) who do not have diabetes. About 250 adults will receive either the drug or a placebo daily for 12 months. The main goals are to see if the drug improves exercise capacity (measured by oxygen use during exercise) and quality of life (via a heart-disease questionnaire).
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medical University of Bialystok
Bialystok, Poland
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National Institute of Cardiology
Warsaw, Poland
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Other studies related to the condition(s) this trial covers.
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