DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called dapagliflozin to see if it can help prevent changes in the heart that can occur after a heart attack, specifically in patients who have left ventricular dysfunction. These changes, known as cardiac remodeling, can lead to heart failure and other serious health issues. The goal is to find out if dapagliflozin can reduce these risks in patients who have experienced an acute myocardial infarction (AMI), which includes types like STEMI and NSTEMI.

To be eligible for this trial, participants must be at least 18 years old and have had a heart attack confirmed by their doctor, along with some degree of heart function impairment. They should not have certain serious conditions like cardiogenic shock or have undergone specific heart surgeries recently. If someone decides to participate, they will need to commit to follow-up visits for six months. The study is currently recruiting participants of all genders who meet these criteria, and they will be closely monitored throughout the trial to ensure their safety and gather important data on the medication's effects.

Gender

ALL

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 ≥ 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).
• 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); 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