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Does the use of empagliflozin improve exercise capacity in patients with hypertrophic cardiomyopathy.
EU CTIS ID: 2024-517643-31-00
What this study is testing
Main objective: to assess whether the use of empagliflozin 10 mg daily for 12 months improves exercise capacity in patients with hypertrophic cardiomyopathy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- written, voluntary informed consent to participate in the study
- diagnosis of hypertrophic cardiomyopathy
- age ≥ 18 years
You likely can't join if
- Refusal to consent to participate in the study
- Recurrent genito-urinary tract infections in the past or currently (For recurrent infections are defined as: two or more infections in the past two months months)
- 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
See the full eligibility criteria
Who can join
- written, voluntary informed consent to participate in the study
- diagnosis of hypertrophic cardiomyopathy
- age ≥ 18 years
What rules you out
- Refusal to consent to participate in the study
- Recurrent genito-urinary tract infections in the past or currently (For recurrent infections are defined as: two or more infections in the past two months months)
- 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
- Diagnosis of diabetes
- 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
- 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
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.