AFFAIR - Alcohol as a Modifiable Risk Factor for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 414
- 主要终点
- Atrial fibrillation recurrence
研究概览
简要总结
Atrial fibrillation (AF) is the most common arrhythmia, diagnosed in approximately 50 million people worldwide. Its prevalence is expected to increase, eventually affecting every third person, which will result in significant healthcare costs. AF symptoms include palpitations, shortness of breath, and fatigue. The condition may lead to discomfort from symptoms and medical treatment, reduced quality of life, and an increased risk of heart failure, stroke, and death. High alcohol intake can cause AF, trigger new episodes and worsen the condition.
The aim of this project is to determine the effect of six months of alcohol abstinence after atrial fibrillation ablation, as modifiable risk factors have gained more attention in the prevention and treatment of AF. Secondly, this study will provide new insights into utilizing a technology platform that enables wearable devices to collect health data remotely. This approach makes ready-to-wear devices a simple and effective solution for monitoring patients' health from home.
The study is designed as an open-label, pragmatic, prospective, 1:1 Randomized Controlled Trial (RCT) that will be preceded by a feasibility study (n=40) that will test the feasibility of the proposed inter-vention for the RCT study. The intervention consists of six months of alcohol abstinence after the ablation procedure. To ensure the best possible chance to succeed with complete alcohol absti-nence, the patients will be offered guidance and support from nurses at the hospital based on the techniques of motivational interviewing.
After evaluating the outcomes of the feasibility study, appropriate adjustments will be made. All participants from the feasibility study will be included in the RCT study.
The study will include a total of 414 participants. The feasibility will be evaluated in five main objec-tives according to the Medical Research Council guidance for designing and evaluating complex in-terventions: Recruitment, data collection, acceptability, resources spent and participant responses.
The primary outcome of the RCT study is AF recurrence after 6 months measured with Withings Scanwatch 2. Secondary outcomes are Number of days with AF, change in AUDIT score, change in symptom burden (AFSS score), change in health-related quality of life (EQ-5D-5L), change in alcohol consumption (self-reported and Peth analysis), change in antiarrhythmic medicine and sick leave days.
Part two of the study will investigate the long-term effect of alcohol abstinence after atrial fibrilla-tion ablation. Primary outcome is time to AF and secondary outcome is re-ablations, hospital admis-sions and antiarrhythmic therapy. Lastly, a cost-utility analysis will be performed.
详细描述
Background
Atrial fibrillation Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and the lifetime risk of de-veloping AF is approximately one out of three. It has a prevalence of approximately 50 million peo-ple worldwide which is expected to increase which entails significant health care costs. AF symp-toms include palpitations, shortness of breath, and fatigue. The condition may lead to discomfort from symptoms and medical treatment, reduced quality of life, and an increased risk of heart fail-ure, stroke, and death. The medical treatment of AF consists of rhythm and rate control together with anticoagulants. Ablation treatment is an effective way to prevent AF episodes, reduce symp-toms and improve quality of life. Sinus rhythm is restored by destroying the electrical impulses that cause the arrhythmia. The cornerstone of the treatment is isolation of the pulmonary veins, where the AF typically originates in otherwise healthy individuals. The electrical impulses can be treated via invasive catheters that reach the heart through the veins in the groin. The long-term success rate varies from 50-80 %. Typically, AF progresses over time from paroxysmal to persistent to per-manent due to structural remodeling of the atrium, described in the literature as 'AF begets AF'. Risk factors for the development of AF include age, male gender, ischemic heart disease, hyperten-sion, and heart failure. In Denmark, the number of ablation treatments is increasing primarily be-cause of an increasing number of AF patients. Modifiable risk factors such as obesity, physical inac-tivity, smoking, and alcohol consumption, have gained more attention in preventing AF and improv-ing the outcome of the treatment of AF. The phenomenon 'holiday heart syndrome' was first de-scribed by Ettinger et al in 1978. It is an alcohol-induced arrhythmia in a person without other clinical evidence of heart disease. Several studies have since then shown a dose-response dependent relationship between alcohol consumption and the development of AF, and even alcohol in small doses is reported to be a common trigger for AF episodes. A recent study involving 140 patients showed that it is possible to reduce the burden of AF by abstaining from alcohol. Alcohol's effect on the recurrence of AF is not yet fully understood but is probably related to an increased number of low-voltage zones in the heart. Evidence about improving the outcome of AF ablation by reduc-ing alcohol intake is scarce and more robust studies are needed to investigate how modifiable risk factors, like alcohol, affect the success rate of ablation treatment. Therefore, this study aims to investigate how alcohol abstinence affects the outcome of atrial fibrillation ablation treatment.
Methods
Design The study is designed as an open-label, pragmatic, prospective, 1:1 Randomized Controlled Trial (RCT) that will be preceded by a feasibility study that will test the feasibility of the proposed intervention for the RCT study. The intervention will be led by health professionals and will focus on alcohol abstinence.
After evaluating the outcomes of the feasibility study any appropriate adjustments will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •All patients >18 years old
- •Referred to a first-time AF or AFL ablation
- •Scores ≥3 on AUDIT/ ≥3 drinks per week
- •Can use the ScanWatch2 as described
排除标准
- •Patients who do not have a Danish social security number
- •Patients who cannot read, and speak Danish fluently
- •Unable to give informed consent.
研究组 & 干预措施
Intervention
Six months of alcohol abstinence after atrial fibrillation ablation treatment.
干预措施: alcohol abstinence (Behavioral)
Control group
The control group receives usual care (SOC) after atrial fibrillation ablation treatment. That means no focused nurse intervention and no restrictions regarding alcohol intake but will be advised according to existing guidelines.
结局指标
主要结局
Atrial fibrillation recurrence
时间窗: 6 months
AF recurrence in the two groups, defined as incidences that last \>30 sec. from 3-6 months. There will be a 3-month blanking period as atrial fibrillation can occur in the first three months after the ablation procedure, even though it has been a successful treatment.
Time to atrial fibrillation (part two)
时间窗: Up to 5 years
We follow all patients until 1 year after including the last patient
次要结局
- Number of days with AF(3 to 6 months)
- Symptom burden assessed with Atrial Fibrillation Severity Scale (AFSS) questionaire(6 months)
- Health Related Quality of Life meassured with the EQ-5D-5L self-reported questionnaire(6 months)
- Alcohol consumption(6 months)
- Fosfatidyletanol (PEth)(3 weeks)
- Antiarrhythmic therapy(6 months)
- Sick leave days(6 months)
- Mortality(6 months)
- Re-ablation procedure (part two)(1 year)
- Hospital admissions (part two)(1 year)
- Antiarrhythmic therapy (part two)(1 year)
- Mortality (part two)(1 year)
研究者
Camilla Nygaard Bring
Clinical nurse specialist and PhD student
Rigshospitalet, Denmark
