Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction
ConditionMyocardial 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Alcohol consumption
BehavioralAfter written consent, patients will enter a run-in period of 2 weeks where they will be asked not to drink any alcohol beverage. Patients with a successful run-in period will be randomized on a 1:1 basis stratified by baseline LVEF (\<50% vs. ≥50%), sex and study site. 110 patients will be assigned to moderate alcohol consumption (1 standard unit a day), and 110 patients to abstinence (no alcohol beverages) for 3 months. We will perform a first echocardiography at randomization and a second at 3 months' follow-up.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Moderate alcohol consumptionNo intervention 0 interventions
Group B: AbstinenceOther 1 intervention
Trial outcomes
Primary outcomes
1
Cardiac function
Measurement of change in left ventricular ejection fraction between baseline visit and 3-month visit
Time frame
3 monthsSponsors and contacts
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Baris Gencer
Lead sponsor
University Hospital, Geneva
Sponsor institution
University of Bern
Collaborator
Swiss National Science Foundation
Collaborator
Source ClinicalTrials.gov