ISGLT2 in Patients Without DM With Acute MI

NCT ID: NCT06903754

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-12-31

Brief Summary

This study will evaluate the effect of ISGLT2 (Dapagliflozin or Empalgliflozin), administered once daily in addition to standard of care treatments for non-diabetic patients with myocardial infarction (MI) treated with PCI, on hospitalization for heart failure, readmissions for acute coronary syndrome and all-cause mortality.

Detailed Description

This is a single-center, prospective study in non-diabetic patients with acute coronary syndrome (ACS) (ST elevation (STEMI) or non-ST elevation (NSTEMI) with left ventricular systolic dysfunction (Defined as Ejection Fraction<50% assessed by 2D Simson Bi-plane echocardiography) or evidence of acute de Novo heart failure. The study will assess the effect of dapagliflozin or empagliflozin versus placebo, administered once daily in addition to standard therapy, on HF hospitalizations, all-cause deaths and ACS readmissions.

Conditions

Acute Coronary Syndromes; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Without ISGLT2

Patients for whom we will not prescribe ISGLT2

With ISGLT2

Intervention Type: DRUG

Patients for whom we will prescribe ISGLT2

Interventions

With ISGLT2

Patients for whom we will prescribe ISGLT2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant must approved the informed consent.
• Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al 2019).
• Evidence of impaired regional or global LV systolic function at any timepoint during current MI-related hospitalisation with Ejection Fraction<50%(established with echocardiogram, radionuclide ventriculogram, contrast angiography or cardiac MRI) or Symptoms of Acute heart failure without cardiogenic Shock.
• Hemodynamically stable (no episodes of symptomatic hypotension, or arrhythmia with haemodynamic compromise in the last 24 hours).

Exclusion Criteria

• Known type 1 diabetes mellitus (T1DM) or T2DM at the time for admission.
• Chronic symptomatic HF with a prior HHF within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
• Patients with cardiogenic shock who received vasoactive drugs during index.
• Hospitalization Severe (eGFR <20 mL/min/1.73 m2 by local laboratory), unstable or rapidly progressing renal disease at the time of randomization
• Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
• Active malignancy requiring treatment at the time of screening.
• Any non-CV condition, eg malignancy, with a life expectancy of less than one years based on the investigator´s clinical judgement.
• Currently on treatment, or with an indication for treatment, with a sodium glucose co-transporter 2 inhibitor (SGLT2-inhibitor)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohammed VI University Hospital

OTHER

Sponsor Role: lead

Responsible Party

BOUCHLARHEM AMINE

CLINICAL CARDIOLOGIST

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mohammed VI university hospital oujda

OUDA, , Morocco

Countries

Morocco

Other Identifiers

DI657483

Identifier Type: -

Identifier Source: org_study_id