Effect of Sleep Apnea Screening and Treatment on Atrial Fibrillation Recurrence : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Time to recurrence of AF after AF ablation.
研究概览
简要总结
The main aim of this project is to assess the effect of Sleep apnea syndrome (SAS) screening (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index >15 / h) on recurrence of atrial fibrillation (AF) over a twenty-four month follow-up period, in patients on optimal medical treatment after AF ablation.
详细描述
Sleep apnea syndrome (SAS) is a common but often undiagnosed disorder associated with substantial cardiovascular morbidity and mortality. SAS prevalence in atrial fibrillation (AF) is 20% to 75%. SAS is associated with both myocardial fibrosis and electrical remodeling which both favor recurrence of AF despite medical treatment or atrial ablation. Proportion of patients with SAS are higher in patients with high-frequency paroxysmal AF and persistent AF than those with low frequency paroxysmal AF. Furthermore, untreated SAS doubles the risk of recurrence of AF after electrical cardioversion. Noteworthy, up to now, given the large number of potential candidates, not all patients with AF are screened for SAS despite recent international guidelines.
Observational studies suggest that treatment of SAS can prevent recurrence of AF episodes but no randomised trial demonstrate this with an adequate level of evidence. In addition, SAS treatment with continuous positive airway pressure (CPAP) has proven its efficacy on other pathologies on cardiovascular outcomes as stroke and to a lesser extend hypertension. In several countries including France, CPAP is reimbursed by national health services. However there are few data on the cost effectiveness of SAS treatment from the standpoint of cardiovascular health costs and no study in AF. Limits of small randomized studies and observational cohorts are fairly illustrated by very recent results of a randomized trial, the SERVE-HF study, which raised the question of central SAS treatment on mortality in systolic heart failure patients. This multicentre randomized trial showed no difference in global mortality between groups, with even an increased OR for cardiovascular death in patients treated for central SAS. In this context, the need of a randomized trial in AF, with a data safety and monitoring board, is even more important to confirm results of observational studies.
Our hypothesis is that SAS screening (and SAS-treatment if screening is positive) in patients presenting with recurrent AF will decrease the risk of recurrence of AF, therefore decreasing associated health costs.
SAS is largely under-diagnosed in AF patients and screening is recommended despite lack of high level-evidences on efficacy of SAS treatment on AF recurrence, and still low resources in terms of SAS screening and absence of cost-effectiveness analysis.
The investigators propose a study design in which patients are randomized for SAS screening in 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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to recurrence of AF after AF ablation.
时间窗: 24 month
To assess the effect of SAS screening (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index \> 15 / h) on recurrence of AF over a twenty-four month follow-up period, in patients on optimal medical treatment after AF ablation.
次要结局
- Number of radiofrequency catheter ablation(24 month)
- Number of hospitalisations for any causes(24 month)
- Measure of health status EQ-5D(24 month)
- Number of cardioversions(24 month)
- AF burden(24 month)
- Number of hospitalisations for cardiovascular reasons(24 month)
- Cost utility analysis of SAS screening by reporting health resource utilization(24 month)
- Number of incident cardiovascular events(24 month)