Actively Recruiting
Dapagliflozin to Reduce Heart Damage After Acute Myocardial Infarction with Left Ventricular Dysfunction
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-12-19
450
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effects of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, on heart patients who have had an acute myocardial infarction (AMI) and have left ventricular (LV) dysfunction. The study aims to assess whether dapagliflozin can reduce cardiac remodeling, which is linked to heart failure and cardiovascular death. This phase III, randomized, double-blind trial focuses on patients with confirmed AMI and reduced ejection fraction (LVEF 64 45%) after percutaneous coronary intervention (PCI). Participants will be randomly assigned to receive either dapagliflozin 10 mg daily or a placebo for six months, alongside standard heart failure care as per current guidelines. Treatment starts soon after hospital admission. The study includes four main visits: baseline and randomization, discharge from the cardiac intensive care unit, a 3-month follow-up, and a 6-month final visit. Heart function will be assessed by transthoracic echocardiography (TTE) at the start and end of the study, with all imaging analyzed centrally by independent cardiologists. During the trial, patients will be monitored for treatment tolerance through scheduled visits and phone calls to confirm no additional SGLT2 inhibitors are taken. Researchers will measure changes in heart function parameters such as left ventricular ejection fraction and left atrium volume. Secondary outcomes include heart volume changes, strain measurements, hospital stay duration, mortality, heart failure worsening, readmissions, biomarker levels, body weight, and adverse events. The total participation lasts six months from randomization.
CONDITIONS
Brief 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 ejection fraction (LVEF) 45% or less
- Completed percutaneous coronary intervention (PCI) or angiography procedure
- Estimated glomerular filtration rate (eGFR) of 25 mL/min/1.73m² or higher
- Systolic blood pressure above 100 mmHg and/or diastolic blood pressure above 70 mmHg before first dosing
- Able to provide written informed consent and willing to participate in 6-month follow-up
- Affiliated with a national health care system (acute myocardial infarction patients excluded)
You will not qualify if you...
- Cardiogenic shock at randomization (systolic blood pressure below 90 mmHg with low output signs or needing inotropic agents)
- Planned surgery for coronary artery bypass grafting (CABG) or treatment of acute complications
- Having any diabetes type other than type 2
- History of diabetic ketoacidosis
- Known contraindication to SGLT-2 inhibitors (e.g., hereditary galactose intolerance)
- More than one episode of severe hypoglycemia in the last 6 months under insulin or sulfonylurea treatment
- Acute symptomatic urinary or genital infection at randomization
- Use of any SGLT-2 inhibitor within 4 weeks before baseline visit
- Poor quality echocardiographic examination preventing analysis
- Inability to evaluate cardiac remodeling by TTE (e.g., pacemaker or defibrillator)
- Atrial fibrillation rhythm at randomization
- Life expectancy less than 6 months
- Known pregnancy or breastfeeding
- Females of childbearing potential without adequate contraception
- Current participation in another interventional trial
- Patients under guardianship or curatorship
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to confirm eligibility including a transthoracic echocardiogram (TTE-1)
Duration - 6 months
Participants receive dapagliflozin or placebo daily for 6 months, on top of standard care, with periodic assessments to monitor treatment tolerance and effects on heart function.
4 visits: baseline and randomization (Visit D0), discharge from CICU (Visit 2), Month 3 (±2 weeks) (Visit 3), and Month 6 (+4 weeks) (Visit 4)
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
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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