NCT05764057RecruitingPhase 3
DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
Recent clinical trials have proven the cardiovascular benefits of new medications for patients with heart failure with reduced ejection fraction (HFrEF), especially sodium-glucose co-transporter 2 (SGLT2) inhibitors. There are no existing randomized clinical trials evaluating the efficacy and safety of dapagliflozin (nor any other SGLT2-inhibitor) to limit cardiac remodeling in patients with acute myocardial infarction (AMI) and left ventricular (LV) dysfunction. Preventing cardiac remodeling, an established predictor of subsequent heart failure (HF) and cardiovascular death, is likely to translate into benefit in reducing clinical events in post-MI patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 1 Mar 2023
- Start date
- 12 Jun 2023
- Primary completion date
- 12 Oct 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Coronary artery disease
- NCT number
- NCT05764057
- EudraCT number
- 2022-001901-28
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 450
- From 12 Jun 2023 to the primary completion date, 12 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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)
Lab values
- History of diabetic ketoacidosis (DKA); Known contra-indication to SGLT-2 inhibitors (hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption);
Other
- 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
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology AP-HP Hôpital européen Georges - Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.