INTRODUCTION:Both types of sleep-disordered breathing (SDB), obstructive and central sleep apnoea (OSA and CSA, respectively), are common in patients with heart failure and reduced ejection fraction (HFrEF). In such patients, SDB is associated with increased cardiovascular morbidity and mortality but it remains uncertain whether treating SDB by adaptive servo-ventilation (ASV) in such patients reduces morbidity and mortality. AIM:ADVENT-HF is designed to assess the effects of treating SDB with ASV on morbidity and mortality in patients with HFrEF. METHODS:ADVENT-HF is a multicentre, multinational, randomized, parallel-group, open-label trial with blinded assessment of endpoints of standard medical therapy for HFrEF alone vs. with the addition of ASV in patients with HFrEF and SDB. Patients with a history of HFrEF undergo echocardiography and polysomnography. Those with a left ventricular ejection fraction ≤45% and SDB (apnoea-hypopnoea index ≥15) are eligible. SDB is stratified into OSA with ≥50% of events obstructive or CSA with >50% of events central. Those with OSA must not have excessive daytime sleepiness (Epworth score of ≤10). Patients are then randomized to receive or not receive ASV. The primary outcome is the composite of all-cause mortality, cardiovascular hospital admissions, new-onset atrial fibrillation requiring anti-coagulation but not hospitalization, and delivery of an appropriate discharge from an implantable cardioverter-defibrillator not resulting in hospitalization during a maximum follow-up time of 5 years. CONCLUSION:The ADVENT-HF trial will help to determine whether treating SDB by ASV in patients with HFrEF improves morbidity and mortality.

译文

简介:两种类型的睡眠障碍呼吸(SDB),阻塞性和中枢性睡眠呼吸暂停(分别为OSA和CSA)在心力衰竭和射血分数降低(HFrEF)的患者中都很常见。在此类患者中,SDB与心血管疾病的发病率和死亡率增加相关,但尚不确定在此类患者中通过适应性伺服通气(ASV)治疗SDB是否会降低发病率和死亡率。
目的:ADVENT-HF旨在评估ASV治疗SDB对HFrEF患者的发病率和死亡率的影响。
方法:ADVENT-HF是一项多中心,多国,随机,平行分组,开放标签的试验,对仅HFrEF的标准药物治疗终点与HFrEF和SDB患者的ASV进行盲法评估。有HFrEF病史的患者接受超声心动图和多导睡眠图检查。左心室射血分数≤45%且SDB(呼吸暂停-呼吸不足指数≥15)的患者符合条件。 SDB分为≥50%阻塞事件的OSA或> 50%中心事件的CSA。患有OSA的人白天不能有过多的嗜睡(Epworth分数≤10)。然后将患者随机接受或不接受ASV。主要结果是所有原因的死亡率,心血管疾病的住院人数,需要抗凝但不需要住院的新发房颤的综合因素,以及从植入式心脏复律除颤器中排出的适当药物不会导致最大随访期间的住院续航时间为5年。
结论:ADVENT-HF试验将有助于确定ASV治疗HFrEF患者的SDB是否能改善发病率和死亡率。

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