DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction

NCT05764057 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Phase 3

Started

2023-06-12

Last updated

2025-12-19

Condition(s) studied

AMISTEMINSTEMILeft Ventricular Dysfunction

Investigational drug(s) / intervention(s)

Dapagliflozin propanediol (FORXIGA™/FARXIGA™1)Placebo comparator

Dapagliflozin propanediol (FORXIGA™/FARXIGA™1): Dapagliflozin (10 mg per day; per os) on top of standard of care as recommended in current guidelines\* for 6 months (experimental group) \*All patients will receive optimal medical therapy (including antithrombotic, beta-blockers, statins, angiotensin converting enzyme inhibitors or angiotensin receptor blocker or sacubitril/valsartan, diuretics, antagonists of the mineralocorticoid receptor) according to their clinical condition as recommended.

Placebo comparator: Placebo daily on top of standard of care as recommended in current guidelines\* for 6 months (control group) \*All patients will receive optimal medical therapy (including antithrombotic, beta-blockers, statins, angiotensin converting enzyme inhibitors or angiotensin receptor blocker or sacubitril/valsartan, diuretics, antagonists of the mineralocorticoid receptor) according to their clinical condition as recommended.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Change in left ventricular ejection fraction (LVEF) from baseline to Month 6 (±1 month) by TTE — 6 months (+4 weeks) from randomization
Two primary endpoints will allow to evaluate two independent and potent predictors of mortality after AMI: 1) Cardiac systolic function, assessed by change in left ventricular ejection fraction (LVEF) from baseline to Month 6 (+4 weeks) ) by TTE; 2) Remodeling, assessed by change in left atrium volume (LAV) from baseline to Month 6 (+4 weeks) by TTE.
Change in left atrium volume (LAV) from baseline to Month 6 (±1 month) by TTE — 6 months (+4 weeks) from randomization
Two primary endpoints will allow to evaluate two independent and potent predictors of mortality after AMI: 1) Cardiac systolic function, assessed by change in left ventricular ejection fraction (LVEF) from baseline to Month 6 (+4 weeks) ) by TTE; 2) Remodeling, assessed by change in left atrium volume (LAV) from baseline to Month 6 (+4 weeks) by TTE.

Trial sites (1)

Facility	City	Region	Status
Department of Cardiology AP-HP Hôpital européen Georges - Pompidou	Paris	France	Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases Recruiting

VExUS in Ards Patients and Association with AKI Recruiting

Periodontitis and Inflammation: Study on Biological Samples Recruiting

Kinematic Analysis of Latissimus Dorsi Transfer Results for Shoulder External Rotation Resuscitation Starting soon

Creation of a Biological Collection for Medical Research Purposes for Patients at the Reference Center for Rare Diseases of the Blood Vessels of the Brain and Eye at Lariboisière Hospital Active, not recruiting

Other trials for the same condition

Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05764057 on ClinicalTrials.gov ↗ ← All trials in France