Actively Recruiting
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction
Led by Baris Gencer · Updated on 2026-04-28
220
Participants Needed
4
Research Sites
152 weeks
Total Duration
On this page
Sponsors
B
Baris Gencer
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalization for acute ST-elevation MI (STEMI) or non ST-elevation MI (NSTEMI) within 365 days prior to screening
- Men and women aged 6 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 will not qualify if you...
- 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
- Nafve 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/1.73m�b2 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.
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Universitätsspital Basel
Basel, Basel, Switzerland, 4031
Actively Recruiting
2
Inselspital
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
3
Centre hospitalier universitaire vaudois
Lausanne, Canton of Vaud, Switzerland, 1005
Actively Recruiting
4
Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1205
Actively Recruiting
Research Team
B
Baris Gencer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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