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

Locations

4
Universitätsspital Basel4031, BaselBasel, Switzerland
Inselspital3010, BernCanton of Bern, Switzerland
Centre hospitalier universitaire vaudois1005, LausanneCanton of Vaud, Switzerland
Hôpitaux Universitaires de Genève1205, Geneva Switzerland

Sponsors and collaborators

Baris Gencer

Lead sponsor

University Hospital, Geneva

Sponsor institution

University of Bern

Collaborator

Swiss National Science Foundation

Collaborator