Could a common diabetes pill prevent heart failure after a heart attack?
NCT ID NCT05764057
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether dapagliflozin, a drug already used for diabetes and heart failure, can help the heart heal better after a heart attack. About 450 adults who have had a heart attack and have weak heart pumping will receive either the drug or a placebo for 6 months. The goal is to see if the drug improves heart function and reduces harmful changes in heart structure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 450 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Cardiology AP-HP Hôpital européen Georges - Pompidou
RECRUITINGParis, 75015, France
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