Impact of sacubitril-valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO-SAS study design.
Impact of sacubitril-valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO-SAS study design.
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DOI：
10.1002/ehf2.12270
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发表时间：
2018-06
影响因子：
3.8
通讯作者：
Roubille F
中科院分区：
文献类型：
--
作者：
Jaffuel D;Molinari N;Berdague P;Pathak A;Galinier M;Dupuis M;Ricci JE;Mallet JP;Bourdin A;Roubille F
睡眠呼吸障碍(SDB)在慢性心力衰竭(CHF)患者中是一种非常普遍的并存疾病，在CHF的病理生理过程中起着有害的作用。然而，在CHF中管理SDB的最佳方式仍然是一个有争议的问题。萨舒比利-val沙坦已被纳入2016年欧洲心脏病学会指南，作为血管紧张素转换酶抑制剂的替代药物，以进一步降低门诊患者心力衰竭进展、住院和死亡的风险。萨舒比利和valsartan是纠正CHF患者SDB的良好候选药物，因为它们已知的作用机制可能抵消CHF患者SDB的病理生理。Entresto-SAS试验是一项为期3个月的多中心、前瞻性、开放标签的真实队列研究。有资格接受萨舒比利-Valsartan治疗的患者(即左室射血分数≤为35%的成年人，尽管接受了血管紧张素转换酶抑制剂、β-受体阻滞剂和盐皮质激素受体拮抗剂的最佳治疗，但仍有症状)将在治疗前和治疗3个月后进行评估(夜间呼吸多谱图、超声心动图、实验室测试、生活质量和SDB问卷)。主要结果是治疗前和治疗3个月后呼吸暂停低通气指数的变化。120名患者被要求检测到呼吸暂停低通气指数显著改善20%，其阿尔法风险为5%，改善能力为90%。在SERVE-HF研究的背景下，医生们正在等待新的试验和替代疗法。在Entresto-SAS试验中，我们试图评估萨舒比利-valsartan是否能改善CHF患者SDB的结局。
Sleep‐disordered breathing (SDB) is a highly prevalent co‐morbidity in patients with chronic heart failure (CHF) and can play a detrimental role in the pathophysiology course of CHF. However, the best way to manage SDB in CHF remains a matter of debate. Sacubitril–valsartan has been included in the 2016 European Society of Cardiology guidelines as an alternative to angiotensin‐converting enzyme inhibitors to further reduce the risk of progression of CHF, CHF hospitalization, and death in ambulatory patients. Sacubitril and valsartan are good candidates for correcting SDB of CHF patients because their known mechanisms of action are likely to counteract the pathophysiology of SDB in CHF. The ENTRESTO‐SAS trial is a 3‐month, multicentric, prospective, open‐label real‐life cohort study. Patients eligible for sacubitril–valsartan treatment (i.e. adults with left ventricular ejection fraction ≤35%, who remain symptomatic despite optimal treatment with an angiotensin‐converting enzyme inhibitor, a beta‐blocker, and a mineralocorticoid receptor antagonist) will be evaluated before and after 3 months of treatment (nocturnal ventilatory polygraphy, echocardiography, laboratory testing, and quality‐of‐life and SDB questionnaires). The primary outcome is the change in the Apnoea–Hypopnoea Index, before and after 3 months of treatment. One hundred twenty patients are required to detect a significant 20% improvement of the Apnoea–Hypopnoea Index with a power of 90% at an alpha risk of 5%. In the context of the SERVE‐HF study, physicians are waiting for new trials and alternative therapies. We sought to assess in the ENTRESTO‐SAS trial whether sacubitril–valsartan could improve the outcome of SDB in CHF patients.
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