DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05764057
Phase
PHASE3
Status
Recruiting
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Conditions

  • AMI
  • Left Ventricular Dysfunction
  • NSTEMI
  • STEMI

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin propanediol (FORXIGA™/FARXIGA™1) — DRUG
    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 — DRUG
    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 Details

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.

Key Dates

Start date
Jun 12, 2023
Status verified
Dec 2025
Primary completion
Oct 12, 2026
Completion
Oct 12, 2026

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin 10mg daily + standard of care
    Dapagliflozin 10mg per day will be administered orally, as in clinical practice
  • Placebo Comparator: Placebo + standard of care
    Placebo will be administered orally

Primary Outcome Measure

Change in left ventricular ejection fraction (LVEF) from baseline to Month 6 (±1 month) by TTE [ Time Frame: 6 months (+4 weeks) from randomization ]

Central Contacts

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