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DAPAgliflozine to attenuate cardiac RemOdeling afTEr aCuTe myOcardial infarction
EU CTIS ID: 2024-511882-13-01
What this study is testing
Assess the efficacy of dapagliflozin, in addition to standard recommended therapy compared to standard recommended therapy alone (i.e. with placebo) on cardiac systolic function and remodeling at 6 months from randomization by transthoracic echocardiography (TTE), in AMI patients with LV dysfunction.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- 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
See the full eligibility 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).
- 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 long-term 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.
- Patients with a known hypersensitivity to dapagliflozin or any of the excipients of the product.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.