Clinical trial NCT06903754: ISGLT2 in Patients Without DM With Acute MI
Official title: Sodium Glucose Cotransporter 2 Inhibitors in Patients Without Diabetes With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Coronary Syndromes
Heart Failure
Keywords: Acute coronary syndronme
ISGLT2
Heart failure
Lead sponsor: Mohammed VI University Hospital
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with Acute coronary syndrome

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.

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)

Primary outcomes:
measure: Primary endpoints
timeFrame: 50 months
Secondary outcomes:
measure: Secondary outcomes
timeFrame: 50 months
Other outcomes:
Locations:
city: Ouda
country: Morocco
facility: Mohammed VI university hospital oujda
Study officials:
References: