Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaris Gencer

About this trial

A total of 220 patients (110 per arm) who report moderate alcohol consumption between 1 and 28 standard units (1 standard unit = \~10 grams) per week in the 12 months prior to hospital admission will be planned for randomization, using a 1:1 ratio to pursue moderate alcohol consumption (1 standard unit per day for women and 2 standard units per day for men) or abstinence (except for one drink on predefined/agreed special occasions) for a total duration of 3 months. An echocardiography will be performed at baseline and 3 months to assess changes in systolic cardiac function (LVEF) for the primary endpoint. A core laboratory team blinded to assignment will perform data interpretation.

Eligibility criteria

Qualifiers

Hospitalization for acute ST-elevation MI (STEMI) or non ST-elevation MI (NSTEMI) within 365 days prior to screening

Men and women aged ≥18 years who are capable and willing to provide consent

ECG ischemic changes, such as persistent or dynamic ST-segment deviation

Evidence of positive high-sensitive troponin

Disqualifiers

High alcohol consumption, defined as an average of >28 alcoholic standard units/week in the 12 months prior to the index hospitalization

Alcohol use disorder (AUDIT score >20 at screening)

History of alcohol or substance abuse

Naïve to alcohol consumption

Trial design

Treatments tested in this trial

  • Alcohol consumption

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Baris Gencer

Lead sponsor

University Hospital, Geneva

Sponsor institution

University of Bern

Collaborator

Swiss National Science Foundation

Collaborator