Using Dapagliflozin to Prevent Heart Changes After a Heart Attack

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial investigates the effectiveness of dapagliflozin, an SGLT2 inhibitor, in preventing cardiac remodeling in patients who have experienced an acute myocardial infarction (AMI) and have left ventricular dysfunction. Eligible participants will be randomized to receive either dapagliflozin or a placebo for six months following their heart attack and standard care. The study will monitor changes in heart function through transthoracic echocardiography at various points during the treatment period. The aim is to determine if dapagliflozin can reduce the risk of heart failure and cardiovascular events in these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Cardiology AP-HP Hôpital européen Georges - Pompidou
  Paris, France Recruiting

Study contacts

• Principal investigator: Etienne PUYMIRAT, Pr — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Etienne PUYMIRAT, Pr
• Email: etienne.puymirat@aphp.fr
• Phone: 00331.56.09.28.51

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.