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

Recruiting now · Not applicable

Conditions studied: Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT05920629

Run by

Baris Gencer

People needed

220

Starts

2023-06-01

Expected to finish

2026-04-30

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Universitätsspital Basel — Basel, Basel, Switzerland (enrolling)
• Inselspital — Bern, Canton of Bern, Switzerland (enrolling)
• Centre hospitalier universitaire vaudois — Lausanne, Canton of Vaud, Switzerland (enrolling)
• Hôpitaux Universitaires de Genève — Geneva, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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