Using Dapagliflozin to Prevent Heart Changes After a Heart Attack

DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction

This study tests if the medication dapagliflozin can help prevent heart problems in people who have had a heart attack and have some heart weakness.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT05764057 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have suffered a STEMI or high-risk NSTEMI with left ventricular dysfunction after a percutaneous coronary intervention.

Not a fit: Patients experiencing cardiogenic shock or those referred for coronary artery bypass grafting will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of heart failure and improve outcomes for patients recovering from a heart attack.

How similar studies have performed: While other studies have shown cardiovascular benefits of SGLT2 inhibitors in heart failure, this specific application in post-AMI patients is novel and has not been extensively tested.

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

Where this trial is running

Paris

• 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

Conditions AMI; STEMI; NSTEMI; Left Ventricular Dysfunction; Acute myocardial infarction; Left ventricular dysfunction; Dapagliflozin; Transthoracic echocardiography