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

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NHS Greater Glasgow and Clyde
• Collaborator: University of Glasgow
• Treatments: Empagliflozin

Criteria

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 ≤40% 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