Empagliflozin in Hypertrophic Cardiomyopathy

Korábbi kezelés

• 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
• 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
• 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
• 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)

Más betegség

• diagnosis of diabetes
• diagnosis of diabetes
• 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
• recurrent genito-urinary tract infections in the past or currently
• musculo-skeletal or neurologic diseases that make it unable to perform cardiopulmonary exercise testing
• heart transplant recipient or listed for heart transplant
• Any severe (obstructive or regurgitant) valvular heart disease expected to lead to surgery during the trial in the Investigator's opinion
• Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at screeining
• 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
• 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
• 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

Laborértékek

• Impaired renal function, defined as eGFR < 30 mL/min/1.73 m2 (CKD-EPI)cr or requiring dialysis,
• 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

Életkor

• age below 18 years

Egyéb

• refusal to consent to participate in the study
• refusal to consent to participate in the study
• life expectancy below 12 months
• pregnancy (currently or planned in the following 12 months)
• breast feeding
• urosepsis in the history
• other contraindications to the use of empagliflozin
• implanted left ventricular assist device
• 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
• Systolic blood pressure (SBP) ≥ 180 mmHg at randomization
• Symptomatic hypotension and/or a SBP < 100 mmHg at screeining or randomization

• written, voluntary informed consent to participate in the study
• diagnosis of hypertrophic cardiomyopathy
• age ≥ 18 years