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

Myocardial Infarction Clinical Trial

— Moderate  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920629
• Other study ID #: 2022-01838
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: November 2023
• Source: University Hospital, Geneva
• Contact: Baris Gencer, MD
• Phone: +4179 55 35 927
• Email: baris.gencer[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 12 months. An echocardiography will be performed at baseline and 12 months to assess changes in systolic cardiac function (LVEF) for the primary endpoint. A core laboratory team blinded to assignment will perform data interpretation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• Alcohol 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 12 months. We will perform a first echocardiography at randomization and a second at 12 months' follow-up.

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern
Switzerland	Hôpitaux Universitaires de Genève	Geneve

Sponsors (3)

Lead Sponsor	Collaborator
Baris Gencer	Swiss National Science Foundation, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac function	Measurement of change in left ventricular ejection fraction between baseline visit and 12-month visit	12 months