Clinical trial NCT05920629: Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction
Official title: Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Bern
name: Swiss National Science Foundation
First posted: 2023-06-27
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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 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.

Primary outcomes:
measure: Cardiac function
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois
state: Vaud
city: Bern
country: Switzerland
facility: Inselspital
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
affiliation: CHUV
name: Baris Gencer, MD
role: PRINCIPAL_INVESTIGATOR
References: