EMpagliflozin to PREvent worSening of Left Ventricular Volumes and Systolic Function After Myocardial Infarction

GN21CA051

The addition of the SGLT2 inhibitor empagliflozin 10mg once daily to standard-of-care therapy administered early following acute myocardial infarction will result in a greater attenuation of adverse left ventricular remodelling, compared with matched placebo, in patients with left ventricular systolic dysfunction as a result of an acute myocardial infarction.

2022-09-16

2024-06-12

2024-06-12

Active (not recruiting)

Early phase I

100

Inclusion Criteria: * • Male or female ≥18 years of age * Informed consent * Diagnosis of a type 1 acute myocardial infarction meeting the Fourth Universal Definition of Myocardial Infarction (STEMI or NSTEMI) * Left ventricular ejection fraction \<45% (changed from ≤40% by an amendment to the trial protocol on 23/Feb/2023) as measured by cardiac MRI performed ≥12 hours and ≤14 days following hospital admission with an acute type 1 myocardial infarction). For patients with an in-hospital myocardial infarction as qualifying event, randomization must still occur within 14 days of hospital admission. * eGFR ≥30 ml/min/1.73m2 at the time of randomisation (calculated using the CKD-EPI formula) Exclusion Criteria: * Inability to give informed consent e.g. due to significant cognitive impairment. * Diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) prior to admission with acute myocardial infarction. * Systolic blood pressure \<90 mmHg at randomisation. * Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation. * Coronary Artery Bypass Grafting (CABG) planned at time of randomisation. * Type II acute myocardial infarction * Any current severe (stenotic) valvular heart disease. * Diagnosis of Takotsubo cardiomyopathy * Type I diabetes mellitus. * History of ketoacidosis. * Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device. * Permanent or persistent atrial fibrillation. * Enrollment in another randomised clinical trial involving medical or device-based interventions (co-enrolment in observational studies is permitted) * Currently pregnant, planning pregnancy, or currently breastfeeding * History of allergy to SGLT2i. * Current or planned use of an SGLT2i at time of randomisation. * Active genital tract infections. * Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons. * Contra-indication to contrast-enhanced cardiac MRI i.e. claustrophobia, metallic foreign object unsuitable for MRI

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2024-04-02