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NCT05920629Recruiting

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

Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 28 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
220 (estimated)
First submitted
14 Feb 2023
Start date
1 Jun 2023
Primary completion date
30 Apr 2026
Lead sponsor
Baris Gencer
NCT number
NCT05920629

What you commit to

  • Study type: Interventional
  • Planned participants: 220
  • From 1 Jun 2023 to the primary completion date, 30 Apr 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • High alcohol consumption, defined as an average of \>28 alcoholic standard units/week in the 12 months prior to the index hospitalization
  • Prior severe heart failure (NYHA III-IV)
  • Any medication (investigator's discretion) making study participation impractical or precluding required follow-up

Other illness

  • Alcohol use disorder (AUDIT score \>20 at screening)
  • History of alcohol or substance abuse
  • 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
  • History of organ transplant

Other

  • Naïve to alcohol consumption
  • Light alcohol consumption (\<1 standard units by week)
  • Severe LV dysfunction at screening (\<30%)
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsspital Basel
Coordinator of this site? Confirm its status
BaselSwitzerlandRecruiting
Inselspital
Coordinator of this site? Confirm its status
BernSwitzerlandRecruiting
Hôpitaux universitaires de Genève
Coordinator of this site? Confirm its status
GenevaSwitzerlandRecruiting
Centre Hospitalier Universitaire Vaudois
Coordinator of this site? Confirm its status
LausanneSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.