Empagliflozin in Hypertrophic Cardiomyopathy

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cardiology, Warsaw, Poland
• Collaborators: Medical University of Bialystok; University of Eastern Finland; VU University Medical Center
• Treatments: Empagliflozin

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