Actively Recruiting
DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-12-19
450
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed STEMI or very high-risk NSTEMI with left ventricular dysfunction (LVEF ≤45%) after PCI or angiography
- Estimated glomerular filtration rate (eGFR) of 25 mL/min per 1.73 m² or higher
- Systolic blood pressure above 100 mmHg and/or diastolic blood pressure above 70 mmHg before first dosing
- Ability to provide written informed consent and willingness to participate in a 6-month follow-up
- Affiliation to a national health care system (AME patients not allowed)
You will not qualify if you...
- Cardiogenic shock at randomization (SBP <90 mmHg with clinical signs of low output or need for inotropic agents)
- Planned surgery for coronary artery bypass grafting or acute complications treatment
- Any diabetes type other than type 2
- History of diabetic ketoacidosis or known contraindication to SGLT2 inhibitors
- More than one episode of severe hypoglycemia within past 6 months under insulin or sulfonylurea treatment
- Acute symptomatic urinary tract or genital infection at randomization
- Use of any SGLT2 inhibitor within 4 weeks prior to baseline
- Echocardiographic exam not suitable for adequate study analysis
- Inability to evaluate cardiac remodeling by transthoracic echocardiogram (e.g., pacemaker or defibrillator)
- Atrial fibrillation at randomization
- Life expectancy less than 6 months
- Known pregnancy or breastfeeding at randomization
- Females of childbearing potential without adequate contraception
- Current participation in another interventional trial
- Patients under guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Cardiology AP-HP Hôpital européen Georges - Pompidou
Paris, France, 75015
Actively Recruiting
Research Team
E
Etienne PUYMIRAT, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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