ISGLT2 in Patients Without DM With Acute MI

Last updated: March 28, 2025
Sponsor: Mohammed VI University Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Angina

Heart Failure

Treatment

With ISGLT2

Clinical Study ID

NCT06903754
DI657483
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria :

  • Participant must approved the informed consent.

  • Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definitionof MI (Thygesen et al 2019).

  • Evidence of impaired regional or global LV systolic function at any timepoint duringcurrent MI-related hospitalisation with Ejection Fraction<50%(established withechocardiogram, radionuclide ventriculogram, contrast angiography or cardiac MRI) orSymptoms of Acute heart failure without cardiogenic Shock.

  • Hemodynamically stable (no episodes of symptomatic hypotension, or arrhythmia withhaemodynamic compromise in the last 24 hours).

Exclusion

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 reducedejection 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 orrapidly progressing renal disease at the time of randomization

  • Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into thetrial.

  • Active malignancy requiring treatment at the time of screening.

  • Any non-CV condition, eg malignancy, with a life expectancy of less than one yearsbased on the investigator´s clinical judgement.

  • Currently on treatment, or with an indication for treatment, with a sodium glucoseco-transporter 2 inhibitor (SGLT2-inhibitor)

Study Design

Total Participants: 450
Treatment Group(s): 1
Primary Treatment: With ISGLT2
Phase:
Study Start date:
October 01, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Mohammed VI university hospital oujda

    Ouda,
    Morocco

    Site Not Available

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