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RECRUITING
NCT05920629
NA

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

Sponsor: Baris Gencer

View on ClinicalTrials.gov

Summary

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.

Official title: Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2023-06-01

Completion Date

2026-04-30

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

BEHAVIORAL

Alcohol consumption

After 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.

Locations (4)

Universitätsspital Basel

Basel, Basel, Switzerland

Inselspital

Bern, Canton of Bern, Switzerland

Centre hospitalier universitaire vaudois

Lausanne, Canton of Vaud, Switzerland

Hôpitaux Universitaires de Genève

Geneva, Switzerland