Status:
UNKNOWN
Empagliflozin in Hypertrophic Cardiomyopathy
Lead Sponsor:
National Institute of Cardiology, Warsaw, Poland
Collaborating Sponsors:
Medical University of Bialystok
University of Eastern Finland
Conditions:
Hypertrophic Cardiomyopathy
Heart Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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. Patient...
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 amou...
Eligibility Criteria
Inclusion
- written, voluntary informed consent to participate in the study
- diagnosis of hypertrophic cardiomyopathy
- age ≥ 18 years
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05182658
Start Date
June 1 2022
End Date
August 1 2024
Last Update
October 26 2023
Active Locations (2)
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1
Medical University of Bialystok
Bialystok, Poland
2
National Institute of Cardiology
Warsaw, Poland