DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction (DAPAPROTECTOR)
AMI, STEMI, NSTEMI
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About this trial
This is an interventional treatment trial for AMI focused on measuring Acute myocardial infarction, Left ventricular dysfunction, Dapaglioflozin, Transthoracic echocardiography, Cardiac remodeling
Eligibility Criteria
Inclusion Criteria: Age ≥18 years; STEMI (e.g., ST elevation above the J-point of ≥0.1 millivolt in ≥two contiguous leads or left bundle branch block) or very high-risk NSTEMI (e.g., dynamic ECG changes or ongoing chest pain or acute heart failure or hemodynamic instability independent of ECG changes or life-threatening ventricular arrhythmias) with LV dysfunction (LVEF ≤45%); after completion of PCI or angiography procedure eGFR ≥30 mL/Min per 1.73m²; Systolic blood pressure (SBP) before first dosing >110 mmHg; Diastolic blood pressure (DBP) before first dosing >70 mmHg; Ability to provide written informed consent and willing to participate in the 6-month follow-up period. Affiliation to a national health care system (AME are not allowed). Exclusion Criteria: Exclusion Criteria : Cardiogenic shock (SBP <90 mmHg with clinical signs of low output or patients requiring inotropic agents) at randomization; Referred to surgery for coronary artery bypass grafting (CABG) or treatment of acute complications (e.g. ventricular septal rupture); Any other form of diabetes than diabetes type 2 History of diabetic ketoacidosis (DKA); Blood pH <7.32; ; Known contra-indication to SGLT-2 inhibitors (hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption); >1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea; Acute symptomatic urinary tract infection (UTI) or genital infection at the time of randomization; Concomitant treatment (and/or within the 4 weeks prior to the baseline visit) with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) Echocardiographic examination of insufficient quality to permit adequate analysis of the study end-points. Impossibility to evaluate cardiac remodeling using TTE (e.g., pacemaker or defibrillator …); Atrial fibrillation rhythm at randomization; Life expectancy <6 month; Known pregnancy at time of randomization; Breastfeeding women Females of childbearing potential without adequate contraceptive methods (i.e. sterilization, intrauterine device, vasectomized partner; or medical history of hysterectomy) Current participation in another interventional trial. Patients under guardianship or curatorship
Sites / Locations
- Department of Cardiology AP-HP Hôpital européen Georges - PompidouRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Dapagliflozin 10mg daily + standard of care
Placebo + standard of care
Dapagliflozin 10mg per day will be administered orally, as in clinical practice
Placebo will be administered orally