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

NCT05020704 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: GN21CA051
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Left ventricular end-systolic volume indexed to body surface area (LVESVI)

  Change in left ventricular end-systolic volume measured by cardiac MR measured in ml/m2

  24 weeks

Secondary Outcomes (7)

• Change in left ventricular end-diastolic volume indexed to body surface area (LVEDVI)

  24 weeks

• Change in left ventricular ejection fraction (LVEF)

  24 weeks

• Change in left atrial volume indexed to body surface area (LAVI)

  24 weeks

• Change in left ventricular mass indexed to body surface area (LVMI)

  24 weeks

• Change in N-terminal pro-B-type natriuretic peptide

  24 weeks

Study Arms (2)

empagliflozin

EXPERIMENTAL

empagliflozin 10mg once daily

Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR

matched placebo

Drug: Placebo

Interventions

Empagliflozin 10 MG DRUG

SGLT2inhibitor

empagliflozin

Placebo DRUG

Matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (3)

Glasgow Royal Infirmary

Glasgow, Strathclyde, G4 0SF, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, G81 4HX, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: September 16, 2022
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

GB (3)