Effects of moderate alcohol consumption on heart function after a heart attack

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.