DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction

Korábbi kezelés

• Referred to surgery for coronary artery bypass grafting (CABG) or treatment of acute complications (e.g. ventricular septal rupture);
• >1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea;
• Concomitant treatment (and/or within the 4 weeks prior to the baseline visit) with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin)

Más betegség

• Any other form of diabetes than diabetes type 2
• Acute symptomatic urinary tract infection (UTI) or genital infection at the time of randomization;
• Impossibility to evaluate cardiac remodeling using TTE (e.g., pacemaker or defibrillator …);
• Females of childbearing potential without adequate contraceptive methods (i.e. sterilization, intrauterine device, vasectomized partner; or medical history of hysterectomy)

Laborértékek

• History of diabetic ketoacidosis (DKA); Known contra-indication to SGLT-2 inhibitors (hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption);

Egyéb

• Cardiogenic shock (SBP <90 mmHg with clinical signs of low output or patients requiring inotropic agents) at randomization;
• Echocardiographic examination of insufficient quality to permit adequate analysis of the study end-points.
• Atrial fibrillation rhythm at randomization;
• Life expectancy <6 month;
• Known pregnancy at time of randomization;
• Breastfeeding women
• Current participation in another interventional trial. Patients under guardianship or curatorship

• 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 ≥ 25 mL/Min per 1.73m²;
• Systolic blood pressure (SBP) before first dosing >100 mmHg and/or Diastolic blood pressure (DBP) >70 mmHg before first dosing;
• 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).