Exercise-induced Cardioversion in Persistent Atrial Fibrillation (ExPAF): A Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of the pilot study - Recruitment rate
研究概览
简要总结
This study aims to to evaluate the feasibility of conducting a larger randomized controlled trial (RCT) to assess whether an exercise stress test on an ergometer bicycle could induce sinus rhythm in patients with persistent AF scheduled for electrical cardioversion and if this intervention (regardless of rhythm conversion) could improve health-related quality of life in these patients.
详细描述
Atrial fibrillation (AF) is one of the most common heart rhythm disorders worldwide. The estimated prevalence of AF in Europe is approximately 2% in the general population and increases with age, reaching 16-24% in individuals aged > 85 years. AF is significantly associated with an increased risk of heart failure, ischemic stroke, cognitive impairment, vascular dementia, and death. Aside from patient suffering, AF is a large economic burden for the healthcare system, where hospitalization is the major driver, accounting for 50-70% of the annual direct costs. Management of patients with AF is multifaceted. The main components include comorbidity and risk factor management (targeting hypertension, diabetes, heart failure), avoidance of stroke and thromboembolism, and reduction of symptoms through rate and rhythm control.
AF episodes may terminate spontaneously, and if they do so within seven days, they are classified as paroxysmal AF. Persistent AF is defined as AF episodes that are not self-terminating. Rhythm control, which involves restoring and maintaining sinus rhythm, is an important part of the management of patients with atrial fibrillation, where the main reason is to reduce symptoms of AF. One alternative treatment is electrical cardioversion (EC), which involves delivering low-energy shocks to the heart in a sedated patient to restore a normal sinus rhythm. A poorly tested alternative to EC in cardioversion is to physically increase the heart rate. In a small observational study, Gates et al. included 18 patients with AF scheduled for EC. The patients underwent a treadmill exercise test, and five (27.8%) converted to sinus rhythm during exercise. None of the patients who failed to convert to sinus rhythm with exercise did so spontaneously before electrical conversion 3 hours to 7 months later. Exercise tests are considered safe when contraindications are adhered to, termination criteria are observed, and appropriately trained personnel administer the tests.
Although EC is effective, it involves hospitalization, anesthesia, and the associated costs and risks. If exercise testing proves to be effective for converting AF to sinus rhythm, it could improve arrhythmia management by offering a non-invasive, cost-effective alternative that empowers patients to manage their condition through home-based programs. This approach not only would reduce hospital dependence and healthcare costs but also enhance cardiovascular fitness and overall quality of life.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18-75 years) with persistent AF
- •planned for EC
- •with at least 3 weeks of therapeutic oral anticoagulation before intervention
排除标准
- •Unable to perform a symptom limited cycle exercise test
- •Ischemic heart disease
- •Heart failure
- •Severe valvular disease
- •Unable to speak and write Swedish language
- •Unable to provide written, informed consent
结局指标
主要结局
Feasibility of the pilot study - Recruitment rate
时间窗: Day 1
Number of patients asked to participate in the study
Feasibility of the pilot study - Consent rate
时间窗: Day 1
Number of patients giving written consent to participate in the study
Feasibility of the pilot study - Study retention
时间窗: Through study completion, an average of 6 months
Participants dropout rates.
Feasibility of the pilot study - Participant fidelity
时间窗: From enrollment to the end of assessments, an average of 2 months
Ability of participants to comply with the intervention protocol.
Feasibility of the pilot study - Adverse events
时间窗: Through study completion, an average of 6 months
Side effects and adverse events during the study
次要结局
- AF conversion to sinus rhythm(Immediately after exercise or electrical conversion)
- Atrial fibrillation-related quality of life(At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion))
- Overall health-related quality of life(At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion))
研究者
Pär Hedberg
Associate Professor, Senior Consultant
Uppsala University
