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NCT Number: NCT05920629

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsspital Basel, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alcohol consumption

Behavioral

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 3 months. We will perform a first echocardiography at randomization and a second at 3 months' follow-up.

Primary outcomes

  1. Cardiac function

    Time frame: 3 months

    Measurement of change in left ventricular ejection fraction between baseline visit and 3-month visit

Study contacts

Contact information is provided by the study sponsor or research team.

Baris Gencer, MD

CONTACT

[email protected]

+41 79 556 59 60

Sponsors and collaborators

Lead sponsor

Baris Gencer

Other

Collaborators

  • Swiss National Science Foundation
  • University of Bern

Registry information

Official study title

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

Acronym: Moderate

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2023
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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