Informations générales (source: ClinicalTrials.gov)
DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2023
janvier 2026
18 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH DE VERSAILLES SITE ANDRE MIGNOT | PUYMIRAT Etienne | 25/10/2025 09:54:08 | Contacter | ||
| HOPITAL NOVO | PUYMIRAT Etienne | 25/10/2025 09:54:10 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 25/10/2025 09:54:09 | Contacter | |||
| AP-HP - Hôpital Ambroise Paré | |||||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Saint Antoine | |||||
Critères
Tous
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).
- 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).
- 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