Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 7
- 主要终点
- Cardiac function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Moderate alcohol consumption
1 standard unit a day for 3 months
Abstinence
No alcohol beverages for 3 months
干预措施: Alcohol consumption (Behavioral)
结局指标
主要结局
Cardiac function
时间窗: 3 months
Measurement of change in left ventricular ejection fraction between baseline visit and 3-month visit
次要结局
未报告次要终点
研究者
Baris Gencer
Principal Investigator
University Hospital, Geneva