EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)

Completed · Phase 3 · Has a placebo group

Conditions studied: Myocardial Infarction

In brief

This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease. People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes. Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.

Key facts

Study ID: NCT04509674
Run by: Boehringer Ingelheim
People needed: 6522
Starts: 2020-12-16
Expected to finish: 2023-11-05
Last updated by the study team: 2025-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Of full age of consent (according to local legislation, at least ≥ 18 years) at screening.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Diagnosis of spontaneous Acute Myocardial Infarction (AMI): ST-Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (NSTEMI) with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital Myocardial Infarction (MI) as qualifying event, randomization must still occur within 14 days of hospital admission.
High risk of HF, defined as EITHER
Symptoms (e.g. dyspnea; decreased exercise tolerance; fatigue), or signs of congestion (e.g. pulmonary rales, crackles or crepitations; elevated jugular venous pressure; congestion on chest X-ray), that require treatment (e.g. augmentation or initiation of oral diuretic therapy; i.v. diuretic therapy; i.v. vasoactive agent; mechanical intervention etc.) at any time during the hospitalization.
OR
Newly developed Left Ventricular Ejection Fraction (LVEF) < 45% as measured by echocardiography, ventriculography, cardiac Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or radionuclide imaging during index hospitalisation.
In addition at least one of the following risk factors:
Age > 65 years,
Newly developed LVEF < 35%,
Prior MI (before index MI) documented in medical records,
Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2 (using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI) formula based on creatinine from local lab at any time during index hospitalisation),
Atrial fibrillation (persistent or permanent ; if paroxysmal, only valid if associated with index MI),
Type 2 diabetes mellitus (prior or new diagnosis),
N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) >1,400 pg/mL for patients in sinus rhythm, >2,800 pg/mL if atrial fibrillation; Brain Natriuretic Peptide (BNP) >350 pg/mL for patients in sinus rhythm, >700 pg/mL if atrial fibrillation, measured at any time during hospitalisation,
Uric acid >7.5 mg/dL (>446 μmol/L), measured at any time during hospitalisation,
Pulmonary Artery Systolic Pressure [or right ventricular systolic pressure] >40 mmHg (non-invasive [usually obtained from clinically indicated post-MI echocardiography] or invasive, at any time during hospitalisation),
Patient not revascularized (and no planned revascularization) for the index MI (Includes e.g. patients where no angiography is performed, unsuccessful revascularization attempts, diffuse atherosclerosis not amenable for intervention; but does NOT include if revascularization was not performed due to nonobstructive coronary arteries),
3-vessel coronary artery disease at time of index MI,
Diagnosis of peripheral artery disease (extracoronary vascular disease, e.g. lower extremity artery disease or carotid artery disease).

You may not qualify if…

Diagnosis of chronic Heart Failure (HF) prior to index MI.
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 planned at time of randomisation.
Current diagnosis of Takotsubo cardiomyopathy.
Any current severe (stenotic or regurgitant) valvular heart disease.
eGFR < 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis.
Type I diabetes mellitus. Further exclusion criteria apply.

Where it is running

Grandview Medical Center — Birmingham, Alabama, United States
Heart Center Research, LLC — Huntsville, Alabama, United States
Mercy Gilbert Medical Center — Gilbert, Arizona, United States
Arkansas Cardiology, PA — Little Rock, Arkansas, United States
Comprehensive Cardiovascular Medical Group — Bakersfield, California, United States
Valley Clinical Trials, Inc. — Covina, California, United States
Cardiovascular Innovation and Research Center — Long Beach, California, United States
University of California Los Angeles — Los Angeles, California, United States
InvivoCure — Mission Hills, California, United States
Valley Clinical Trials, Inc. — Northridge, California, United States
Valley Clinical Trials, Inc. — Pasadena, California, United States
Kaiser Permanente — San Diego, California, United States
San Diego Cardiac Center — San Diego, California, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
Interventional Cardiology Medical Group — West Hills, California, United States
George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
Integrative Research Associates — Fort Lauderdale, Florida, United States
University of Florida Health Jacksonville — Jacksonville, Florida, United States
Cardiology Partners Clinical Research Institute — Palm Beach Gardens, Florida, United States
Charlotte Heart Group Research Center — Port Charlotte, Florida, United States
Grady Memorial Hospital — Atlanta, Georgia, United States
Cardiovascular Consultants of South Georgia, LLC — Thomasville, Georgia, United States
Atlanta Heart Specialists, LLC — Tucker, Georgia, United States
Advanced Cardiovascular LLC — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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