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AMI
+3

DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction

Sponsored by Assistance Publique - Hôpitaux de Paris

About this trial

Last updated 2 years ago

Study ID

APHP211054

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial 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.

What are the Participation Requirements?

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 ≥30 mL/Min per 1.73m²;

- Systolic blood pressure (SBP) before first dosing >110 mmHg;

- Diastolic blood pressure (DBP) before first dosing >70 mmHg;

- 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:

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);

- Blood pH <7.32;

- ; 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

Locations

Location

Status

Recruiting