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

NCT ID: NCT05920629

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-04-30

Brief Summary

A total of 220 patients (110 per arm) who report moderate alcohol consumption between 4 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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Moderate alcohol consumption

1 standard unit a day for 3 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Abstinence

No alcohol beverages for 3 months

Group Type: OTHER

Alcohol consumption

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• Confirmation of coronary heart disease aetiology by angiography
• Capacity to complete study visits with strict adherence to the protocol assignment
• Self-reported average alcohol consumption of between 4 and 28 standard units per week in the 12 months prior to the index hospitalization.

Exclusion Criteria

• 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
• Light alcohol consumption (<4 standard units by week)
• Prior severe heart failure (NYHA III-IV)
• Severe LV dysfunction at screening (<30%)
• History of gastric ulcer or gastro-intestinal bleeding
• Serious chronic liver disease or liver test elevation (> 3 times upper limit normal range)
• Personal history of any colon or liver cancer
• Any active malignancy (less than 5 years or ongoing treatment)
• Estimated glomerular filtration rate 15 ml/min/1.73m² or end-stage renal disease
• Any medication (investigator's discretion) making study participation impractical or precluding required follow-up
• History of organ transplant
• Participation in another trial testing intervention on similar CV outcomes (investigator's discretion)
• Any medical, geographic, or social factor making study participation impractical or precluding required follow-up.
• Pregnant, breastfeeding or planning to become pregnant within 12 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: collaborator

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

Baris Gencer

OTHER

Sponsor Role: lead

Responsible Party

Baris Gencer

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Baris Gencer, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

Centre hospitalier universitaire vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Inselspital

Bern, , Switzerland

Site Status: RECRUITING

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Baris Gencer, MD

Role: CONTACT

baris.gencer@chuv.ch

+41 79 556 59 60

Facility Contacts

Baris Gencer

Role: primary

baris.gencer@chuv.ch

Lorenz Raber

Role: primary

lorenz.raeber@insel.ch

François Mach

Role: primary

francois.mach@hug.ch

Other Identifiers

2022-01838

Identifier Type: -

Identifier Source: org_study_id