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

Not Applicable

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Behavioral: Alcohol consumption

• Registration Number: NCT05920629
• Lead Sponsor: Baris Gencer

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 for 12 months) 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-14
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-16
• Study First Posted: 2023-06-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abstinence	Alcohol consumption	No alcohol beverages for 12 months

Primary Outcome Measures

Name	Time	Method
Cardiac function	12 months	Measurement of change in left ventricular ejection fraction between baseline visit and 12-month visit

Trial Locations

Locations (2)

Inselspital; 🇨🇭 Bern, Switzerland

Hôpitaux Universitaires de Genève; 🇨🇭 Geneve, Switzerland