Effects of moderate alcohol consumption on heart function after a heart attack
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial
This study is testing whether drinking a moderate amount of alcohol can help improve heart function in people who have recently had a heart attack.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 4 sites (Basel, Basel and 3 other locations) |
| Trial ID | NCT05920629 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of moderate alcohol consumption on heart function in patients who have experienced a recent myocardial infarction. A total of 220 patients will be randomly assigned to either continue moderate alcohol consumption or abstain for three months. The primary endpoint will be assessed through echocardiography to measure changes in left ventricular ejection fraction (LVEF) at baseline and after three months. The study will ensure that data interpretation is conducted by a blinded core laboratory team to maintain objectivity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for a myocardial infarction within the past year and report moderate alcohol consumption.
Not a fit: Patients with a history of high alcohol consumption, alcohol use disorder, or those who do not consume alcohol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into whether moderate alcohol consumption can positively influence heart recovery after a myocardial infarction.
How similar studies have performed: While there is ongoing debate regarding alcohol consumption and heart health, this specific approach has not been extensively tested in similar studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Basel, Basel and 3 other locations
- Universitätsspital Basel — Basel, Basel, Switzerland (Recruiting)
- Inselspital — Bern, Canton of Bern, Switzerland (Recruiting)
- Centre hospitalier universitaire vaudois — Lausanne, Canton of Vaud, Switzerland (Recruiting)
- Hôpitaux Universitaires de Genève — Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Baris Gencer, MD — Chuv
- Study coordinator: Baris Gencer, MD
- Email: baris.gencer@chuv.ch
- Phone: +41 79 556 59 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.