Status:
COMPLETED
ISGLT2 in Patients Without DM With Acute MI
Lead Sponsor:
Mohammed VI University Hospital
Conditions:
Acute Coronary Syndromes
Heart Failure
Eligibility:
All Genders
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...
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 (De...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06903754
Start Date
October 1 2021
End Date
December 31 2024
Last Update
September 15 2025
Active Locations (1)
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1
Mohammed VI university hospital oujda
OUDA, Morocco