Alcohol Intake and Heart Pumping Strength After a Heart Attack

Trial details

Who runs it

Baris Gencer

Trial code

NCT05920629

Record updated

28 April 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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; 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; 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.

ClinicalTrials.gov NCT05920629