Hypertrophic CardiomyopathyPhase 3EMPA-REPAIRNCT05182658
Empagliflozin in Hypertrophic Cardiomyopathy
A Phase 3 study testing Empagliflozin 10 MG in people with Hypertrophic Cardiomyopathy and Heart Failure, run by National Institute of Cardiology, Warsaw, Poland at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Heart Failure
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jun 2022to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written, voluntary informed consent to participate in the study
- diagnosis of hypertrophic cardiomyopathy
- age ≥ 18 years
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Medical University of Bialystok
Bialystok
National Institute of Cardiology
Warsaw
About this study
Official title: The Use of Empagliflozin in Patients With Hypertrophic Cardiomyopathy
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.
Read the detailed description
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 the bloodstream. Its inhibition in people with type 2 diabetes leads to an increase in urinary glucose excretion and a decrease in its concentration in the blood. In the study in patients with type 2 diabetes and high cardiovascular risk, the use of empagliflozin was associated with a significant decrease in mortality and the number of hospitalizations due to heart failure. The mechanisms responsible for beneficial effects of empagliflozin are not fully understood. It is underlined that effects leading to a reduction of oxidative stress, improvement of diastolic function, inhibition of myocardial fibrosis and, what is important, improvement of myocardial energy status and reduction of cardiomyocyte calcium overload, increase of sarcoplasmic reticulum Ca2+ ATPase 2 (SERCA2) activity, which are important pathophysiological mechanisms of HCM, leading to progressive myocardial hypertrophy and the development of heart failure.
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 endpoints of the study will be:
- change in peak oxygen uptake (VO2 max) measured in a cardiopulmonary exercise test.
- change in 23-item KCCQ-OSS
VO2max is an objective indicator of physical performance and will be evaluated before and after empagliflozin or placebo treatment. Secondary endpoints will be a change in the maximum left ventricular wall thickness, left ventricular mass, parameters of diastolic dysfunction, severity of myocardial fibrosis and improvement of its energy status.
An important aspect of the study will be the genetic analysis of the study group. Data in both human and experimental studies indicate that the benefits of treatment may be dependent on the patient's genotype. The pathomechanisms of heart failure development differ depending on the mutation found and the prognosis of patients is the worst in the case of HCM phenocopies as well as in patients with pathogenic variants in sarcomeric genes. It is therefore justified to examine the genetic profile of the population being studied. For this purpose, next generation sequencing (NGS) with whole exome sequencing (WES) is planned. This will detect both known and unknown variants in the genes responsible for developing HCM. In addition, the investigators hypothesized that the beneficial cardiac effects of empagliflozin may be dependent on genes involved in the pathophysiology of diabetes, and a separate research task with the participation of a foreign partner (University of Eastern Finland) was devoted to this issue.
The investigators believe that the social benefit of the project is greater than its costs, giving the prospect of treating a disease for which modern medicine turns out to be insufficient. Preventing the development of heart failure among patients with HCM, apart from the benefit for the patients themselves, will also translate into economic benefits for the health care and the social systems
- Conditions
- Hypertrophic Cardiomyopathy, Heart Failure
- Being tested
- Empagliflozin 10 MG, Placebo
- Keywords
- Hypertrophic cardiomyopathy, Heart Failue, Empagliflozin, Sodium-glucose transport protein 2 inhibitor, SGLT2 inhibitor
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Jardiance
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin group | Active comparator | Patients in the empagliflozin group will receive 10 mg of empagliflozin once daily for 12 months Receives: Drug: Empagliflozin 10 MG |
| Control group | Placebo comparator | Patients in the control group will receive placebo once daily for 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%)
Change in peak VO2 measured in the cardiopulmonary exercise testing in patients with reduced left ventricular ejection fraction (EF <50%)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Jun 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Bialystok, University of Eastern Finland, Amsterdam UMC, location VUmc
- Responsible party
- Sponsor
- Investigators
- Mateusz Śpiewak, MD, PhD, Principal investigator, National Institute of Cardiology, Department of Radiology, Magnetic Resonance UnitMariusz Kłopotowski, MD, PhD, Principal investigator, National Institute of Cardiology, Department of Cardiology and Interventional AngiologyKarol Kamiński, Professor, Principal investigator, Medical University of Bialystok, Department of Population Medicine and Lifestyle Diseases Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182658
- Sponsor's protocol ID
- 2020/ABM/01/00001
- Acronym
- EMPA-REPAIR
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2021
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Empagliflozin in Patients With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05182658
- Acronym / sponsor ID
- EMPA-REPAIR / 2020/ABM/01/00001
- Conditions
- Hypertrophic Cardiomyopathy, Heart Failure
- Keywords
- Hypertrophic cardiomyopathy, Heart Failue, Empagliflozin, Sodium-glucose transport protein 2 inhibitor, SGLT2 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Medical University of Bialystok, University of Eastern Finland, Amsterdam UMC, location VUmc
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 the bloodstream. Its inhibition in people with type 2 diabetes leads to an increase in urinary glucose excretion and a decrease in its concentration in the blood. In the study in patients with type 2 diabetes and high cardiovascular risk, the use of empagliflozin was associated with a significant decrease in mortality and the number of hospitalizations due to heart failure. The mechanisms responsible for beneficial effects of empagliflozin are not fully understood. It is underlined that effects leading to a reduction of oxidative stress, improvement of diastolic function, inhibition of myocardial fibrosis and, what is important, improvement of myocardial energy status and reduction of cardiomyocyte calcium overload, increase of sarcoplasmic reticulum Ca2+ ATPase 2 (SERCA2) activity, which are important pathophysiological mechanisms of HCM, leading to progressive myocardial hypertrophy and the development of heart failure.
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 endpoints of the study will be:
- change in peak oxygen uptake (VO2 max) measured in a cardiopulmonary exercise test.
- change in 23-item KCCQ-OSS
VO2max is an objective indicator of physical performance and will be evaluated before and after empagliflozin or placebo treatment. Secondary endpoints will be a change in the maximum left ventricular wall thickness, left ventricular mass, parameters of diastolic dysfunction, severity of myocardial fibrosis and improvement of its energy status.
An important aspect of the study will be the genetic analysis of the study group. Data in both human and experimental studies indicate that the benefits of treatment may be dependent on the patient's genotype. The pathomechanisms of heart failure development differ depending on the mutation found and the prognosis of patients is the worst in the case of HCM phenocopies as well as in patients with pathogenic variants in sarcomeric genes. It is therefore justified to examine the genetic profile of the population being studied. For this purpose, next generation sequencing (NGS) with whole exome sequencing (WES) is planned. This will detect both known and unknown variants in the genes responsible for developing HCM. In addition, the investigators hypothesized that the beneficial cardiac effects of empagliflozin may be dependent on genes involved in the pathophysiology of diabetes, and a separate research task with the participation of a foreign partner (University of Eastern Finland) was devoted to this issue.
The investigators believe that the social benefit of the project is greater than its costs, giving the prospect of treating a disease for which modern medicine turns out to be insufficient. Preventing the development of heart failure among patients with HCM, apart from the benefit for the patients themselves, will also translate into economic benefits for the health care and the social systems
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin group | Active comparator | Drug: Empagliflozin 10 MGPatients in the empagliflozin group will receive 10 mg of empagliflozin once daily for 12 months |
| Control group | Placebo comparator | Drug: PlaceboPatients in the control group will receive placebo once daily for 12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written, voluntary informed consent to participate in the study
- diagnosis of hypertrophic cardiomyopathy
- age ≥ 18 years
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGAlso: JardianceThe 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 | Empagliflozin group |
| PlaceboThe 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. | Drug | Control group |
Primary outcome
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.
Time frame: 12 months
Change in peak VO2 measured in the cardiopulmonary exercise testing and Change in 23-item KCCQ-OSS.
1 secondary outcome
Secondary outcome: Change in peak VO2 measured in the cardiopulmonary exercise testing in patients with reduced left ventricular ejection fraction (EF <50%)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mateusz Śpiewak, MD, PhD principal investigator
National Institute of Cardiology, Department of Radiology, Magnetic Resonance Unit
Mariusz Kłopotowski, MD, PhD principal investigator
National Institute of Cardiology, Department of Cardiology and Interventional Angiology
Karol Kamiński, Professor principal investigator
Medical University of Bialystok, Department of Population Medicine and Lifestyle Diseases Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin 10 MG in people with Hypertrophic Cardiomyopathy and Heart Failure, run by National Institute of Cardiology, Warsaw, Poland at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.