A Randomized Controlled Trial to Assess Abstinence of Coffee Compared to Continued Consumption on Recurrent Atrial Fibrillation Following Cardioversion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Number of participants with first confirmed clinical recurrence of AF or atrial flutter, or device-detected recurrence lasting longer than 30 seconds, analyzed as a time-to-event outcome
研究概览
简要总结
Given both the increasing population impact of atrial fibrillation (AF) and the widespread consumption of coffee in society, determining an associated benefit or risk of coffee consumption on AF is of great clinical relevance. This study will evaluate the effect of randomly assigning participants undergoing cardioversion to coffee abstinence or coffee continuation over a 6 month period. This study will provide the first, randomized evaluation of coffee on AF outcomes and will provide important information on whether or not coffee has any effect on AF recurrence.
详细描述
The purpose of this study is to assess how abstinence of coffee compared to continued consumption affects recurrent atrial fibrillation (AF) following cardioversion. As one of the most consumed beverages in the world, whether coffee has any effect on health outcomes is of considerable interest to physicians, scientists, and individual consumers. While significant data exist on the potential impact of coffee on many cardiometabolic parameters, there is conflicting data on any role of coffee on AF.
Most studies so far have been observational in nature, limiting how much insight there is on the role of coffee on AF. This study proposes to directly compare AF outcomes for patients with AF that abstain from coffee versus those that continue coffee consumption.
A total of 200 AF patients undergoing cardioversion will be enrolled in this study (100 per arm), and followed for up to 6 months post cardioversion. Differences in AF recurrence and symptoms will be compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥ 21 years of age
- •Sustained AF or atrial flutter (provided patient has a history of AF)
- •Planned/scheduled direct current electrical cardioversion
- •Consumption greater than or equal to one cup of coffee per day sometime in the past 5 years
- •Willing and able to comply with coffee abstinence or continuation for at least 6 months
- •Life expectancy of at least 6 months
- •Willing and able to return and comply with scheduled phone follow up visits
- •Willing and able to provide written informed consent
排除标准
- •Established allergy or adverse reaction to coffee
- •Stated inability to comply with coffee abstinence or continuation
- •AF ablation in preceding 3 months or planned in next 3 months
- •Recent cardiothoracic surgery in preceding 3 months
- •Pregnancy or desire to get pregnant within next 6 months.
- •Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study
- •Any other criteria, which would make the patient unsuitable to participate in this study as determined by the Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)
结局指标
主要结局
Number of participants with first confirmed clinical recurrence of AF or atrial flutter, or device-detected recurrence lasting longer than 30 seconds, analyzed as a time-to-event outcome
时间窗: 6 months
The number and rate of AF or atrial flutter recurrence following cardioversion in the coffee abstinence group and the continued coffee group will be compared
次要结局
- Adverse events(6 months)
- Recurrent atrial flutter or AF separately(6 months)