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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

Recruiting
18 years and older
All
Phase N/A

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Overview

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 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.

Eligibility

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 4 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 (<4 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.

Study details
    Myocardial Infarction

NCT05920629

Baris Gencer

5 June 2025

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