empagliflozin for Hypertrophic cardiomyopathy

Inclusion criteria

• {"criterion_text":"- written, voluntary informed consent to participate in the study\n- diagnosis of hypertrophic cardiomyopathy\n- age ≥ 18 years"}

Exclusion criteria

• {"criterion_text":"- Refusal to consent to participate in the study\n- 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)\n- Urosepsis in the history\n- Impaired renal function, defined as eGFR < 30 mL/min/1.73 m2 (CKD-EPI)cr or requiring dialysis,\n- Other contraindications to the use of empagliflozin\n- Musculo-skeletal or neurologic diseases that make it unable to perform cardiopulmonary exercise testing\n- Heart transplant recipient or listed for heart transplant\n- Implanted left ventricular assist device\n- Any severe (obstructive or regurgitant) valvular heart disease expected to lead to surgery during the trial in the Investigator's opinion\n- 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\n- Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at screeining\n- Diagnosis of diabetes\n- Systolic blood pressure (SBP) ≥ 180 mmHg at randomization\n- Symptomatic hypotension and/or a SBP < 100 mmHg at screeining or randomization\n- 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\n- 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\n- Haemoglobin < 9 g/dl at screening\n- 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\n- Gastrointestinal (GI) surgery or GI disorder that could interfere with absorption of trial medication in the investigator's opinion\n- 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\n- History of ketoacidosis\n- Patients who must or wish to continue the intake of any drug considered likely to interfere with the safe conduct of the trial\n- 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\n- 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)\n- 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\n- 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\n- ICD or cardiac pacemaker (for a group of patients in whom cardiac magnetic resonance study will be performed; n=100)\n- Planned implantation of cardiac resynchronization therapy (CRT of CRT-D) in the following 12 months\n- Life expectancy below 12 months\n- Pregnancy (currently or planned in the following 12 months)\n- Breast feeding\n- Age below 18 years"}

Primary endpoints

• {"endpoint_text":"- A test of the null hypothesis that the mean VO 2 max measured 12 months after randomization is the same in the treatment group and the placebo group;","definition_or_measurement_approach":"Mean VO2 max measured 12 months after randomization; comparison of mean VO2 max between treatment (empagliflozin) and placebo groups."}
• {"endpoint_text":"- A null hypothesis test that the mean KCCQ-OS value measured 12 months after randomization is the same in the treatment group and the placebo group.","definition_or_measurement_approach":"Mean KCCQ-OS (Kansas City Cardiomyopathy Questionnaire overall summary) value measured 12 months after randomization; comparison between treatment and placebo groups."}

Secondary endpoints

• {"endpoint_text":"- The secondary objective of the trial is to test the null hypothesis that the mean value of the VO 2 max measured 12 months after randomization is the same in the treatment group treated group and the placebo group among patients with reduced left ejection fraction ventricle.","definition_or_measurement_approach":"Mean VO2 max measured 12 months after randomization in the subgroup of patients with reduced left ventricular ejection fraction (EF <50%); comparison between treatment and placebo groups in that subgroup."}

Poland

Earliest CTIS Part Ii Submission Date

04-10-2024

Latest Decision Or Authorization Date

11-11-2024

Processing Time Days

38

Number Of Sites

2

Number Of Participants

250

Primary sponsor

Full Name

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Scientia Research Institute Sp. z o.o.","duties_or_roles":"sponsorDuties codes: 1, 10, 6, 7, 9","organisation_type":"Pharmaceutical company"}