Acute Coronary Syndromes, Heart Failure
Conditions
Keywords
Acute coronary syndronme, ISGLT2, Heart failure
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.
Interventions
DRUGWith ISGLT2
Patients for whom we will prescribe ISGLT2
Sponsors
Mohammed VI University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoints | 50 months | Time to the first occurrence of any of the components of this composite: hospitalization for heart failure (HHF), Non fatal Myocardial infarction (MI) or Death from all causes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcomes | 50 months | Time to the first occurrence of a fatal or a non-fatal MI \[Time Frame: From admission visit (Day 0) up to approximately 4.2years\] Time to first hospitalisation for Heat failure \[Time Frame: From admission visit (Day 0) up to approximately 3 years\] Time to death of any cause \[Time Frame: From admission visit (Day 0) up to approximately 4.2 years\] Time to new onset of type 2 diabetes mellitus (T2DM) post discharge \[Time Frame: From admission (Day 0) up to approximately 4.2 years\] Time to new onset atrial fibrilation (AF) post discharge \[Time Frame: From admission visit (Day 0) up to approximately 4.2 years\] |
Countries
Morocco
Outcome results
None listed