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

April 22, 2026 updated by: Baris Gencer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève
        • Contact:
    • Basel
      • Basel, Basel, Switzerland, 4031
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3010
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1005
        • Recruiting
        • Centre Hospitalier Universitaire Vaudois
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 1 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 (<1 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Moderate alcohol consumption
1 standard unit a day for 3 months
Other: Abstinence
No alcohol beverages for 3 months
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function
Time Frame: 3 months
Measurement of change in left ventricular ejection fraction between baseline visit and 3-month visit
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baris Gencer

Collaborators

Swiss National Science Foundation
University of Bern

Investigators

  • Principal Investigator: Baris Gencer, MD, CHUV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01838

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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