DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
Department of Cardiology AP-HP Hôpital européen Georges - Pompidou
RECRUITING
Paris
Contact Information
Primary
Etienne PUYMIRAT, Pr
etienne.puymirat@aphp.fr
00331.56.09.28.51
Time Frame
Start Date: 2023-06-12
Estimated Completion Date: 2026-01-09
Participants
Target number of participants: 450
Treatments
Experimental: Dapagliflozin 10mg daily + standard of care
Dapagliflozin 10mg per day will be administered orally, as in clinical practice
Placebo_comparator: Placebo + standard of care
Placebo will be administered orally
Related Therapeutic Areas
Sponsors
Collaborators: AstraZeneca
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov