RecruitingNot ApplicableNCT05920629

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: a Multicentre Randomized Controlled Trial

Sponsor

Baris Gencer

Enrollment

220 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Myocardial Infarction

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria17

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.

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Interventions

BEHAVIORALAlcohol consumption

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.