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

NCT05920629 | Recruiting

• 1 other identifier: 2022-01838
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Cardiac function

  Measurement of change in left ventricular ejection fraction between baseline visit and 3-month visit

  3 months

Study Arms (2)

Moderate alcohol consumption

NO INTERVENTION

1 standard unit a day for 3 months

Abstinence

OTHER

No alcohol beverages for 3 months

Behavioral: Alcohol consumption

Interventions

Alcohol consumption 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.

Abstinence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baris Gencer: lead
• University of Bern: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (4)

Universitätsspital Basel

Basel, Basel, 4031, Switzerland

RECRUITING

Inselspital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Centre hospitalier universitaire vaudois

Lausanne, Canton of Vaud, 1005, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Baris Gencer, MD

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baris Gencer, MD

CONTACT

+41 79 556 59 60; baris.gencer@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: June 27, 2023
• Study Start: June 1, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-03

Locations

CH (4)