Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction
Study Details
Study Description
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 12 months. An echocardiography will be performed at baseline and 12 months to assess changes in systolic cardiac function (LVEF) for the primary endpoint. A core laboratory team blinded to assignment will perform data interpretation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Moderate alcohol consumption 1 standard unit a day for 12 months |
|
| Other: Abstinence No alcohol beverages for 12 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 12 months. We will perform a first echocardiography at randomization and a second at 12 months' follow-up.
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Outcome Measures
Primary Outcome Measures
- Cardiac function [12 months]
Measurement of change in left ventricular ejection fraction between baseline visit and 12-month visit
Eligibility Criteria
Criteria
Inclusion Criteria:
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Hospitalization for acute ST-elevation MI (STEMI) or non ST-elevation MI (NSTEMI) within 365 days prior to screening
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Men and women aged ≥18 years who are capable and willing to provide consent
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ECG ischemic changes, such as persistent or dynamic ST-segment deviation
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Evidence of positive high-sensitive troponin
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Confirmation of coronary heart disease aetiology by angiography
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Capacity to complete study visits with strict adherence to the protocol assignment
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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:
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High alcohol consumption, defined as an average of >21 alcoholic standard units/week in the 12 months prior to the index hospitalization
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Alcohol use disorder (AUDIT score >20 at screening)
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History of alcohol or substance abuse
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Naïve to alcohol consumption
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Light alcohol consumption (<4 standard units by week)
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Prior severe heart failure (NYHA III-IV)
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Severe LV dysfunction at screening (<40%)
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History of gastric ulcer or gastro-intestinal bleeding
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Serious chronic liver disease or liver test elevation (> 3 times upper limit normal range)
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Personal history of any colon or liver cancer
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Any active malignancy (less than 5 years or ongoing treatment)
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Estimated glomerular filtration rate 15 ml/min/1.73m² or end-stage renal disease
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Any medication (investigator's discretion) making study participation impractical or precluding required follow-up
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History of organ transplant
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Participation in another trial testing intervention on similar CV outcomes (investigator's discretion)
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Any medical, geographic, or social factor making study participation impractical or precluding required follow-up.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inselspital | Bern | Switzerland | 3010 | |
| 2 | Hôpitaux Universitaires de Genève | Geneve | Switzerland | 1205 |
Sponsors and Collaborators
- Baris Gencer
- University of Bern
- Swiss National Science Foundation
Investigators
- Principal Investigator: Baris Gencer, MD, University Hospital, Geneva
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-01838