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

Launched by BARIS GENCER · Jun 16, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how moderate alcohol consumption affects heart function in patients who have recently experienced a heart attack, known as a myocardial infarction. The study involves 220 participants who have been drinking alcohol moderately (between 4 and 28 standard units per week) in the year before their hospital admission. Participants will be randomly assigned to either continue consuming moderate amounts of alcohol (1 drink per day for women and 2 for men) or to abstain from alcohol for 12 months, with a few exceptions for special occasions. Researchers will use echocardiograms, which are ultrasound tests of the heart, to measure any changes in heart function at the beginning and end of the study.

To be eligible for this trial, participants must be at least 18 years old and have been hospitalized for a heart attack within the past year. They should also be able to provide consent and follow the study's guidelines. However, individuals with a history of heavy drinking, alcohol use disorders, severe heart failure, or certain medical conditions will not be eligible. Throughout the trial, participants can expect regular check-ins and assessments to monitor their heart health and adherence to their assigned drinking plan. This study is important because it aims to provide insights into how moderate drinking might influence heart recovery after a heart attack.

Gender

ALL

Eligibility criteria

• 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.