NCT05920629 Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction
| NCT ID | NCT05920629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baris Gencer |
| Condition | Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2023-06-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 1 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 (\<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.
Contact & Investigator
Baris Gencer, MD
PRINCIPAL INVESTIGATOR
CHUV
Frequently Asked Questions
Who can join the NCT05920629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05920629 currently recruiting?
Yes, NCT05920629 is actively recruiting participants. Contact the research team at baris.gencer@chuv.ch for enrollment information.
Where is the NCT05920629 trial being conducted?
This trial is being conducted at Basel, Switzerland, Bern, Switzerland, Lausanne, Switzerland, Geneva, Switzerland.
Who is sponsoring the NCT05920629 clinical trial?
NCT05920629 is sponsored by Baris Gencer. The principal investigator is Baris Gencer, MD at CHUV. The trial plans to enroll 220 participants.