The Sleep Apnea cardioVascular Endpoints (SAVE) Trial: Rationale, Ethics, Design, and Progress
The Sleep Apnea cardioVascular Endpoints (SAVE) Trial: Rationale, Ethics, Design, and Progress
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DOI：
10.5665/sleep.4902
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发表时间：
2015-08-01
期刊：
影响因子：
5.6
通讯作者：
McEvoy, R. Doug
中科院分区：
文献类型：
--
作者：
Antic, Nick A.;Heeley, Emma;McEvoy, R. Doug
睡眠呼吸暂停心血管终点（SAVE）研究是一项正在进行的、由研究者发起并实施的国际、多中心、开放、设盲终点研究，一项随机对照试验，旨在确定采用持续气道正压通气（CPAP）治疗阻塞性睡眠呼吸暂停（OSA）是否可降低已确诊CV疾病患者发生严重心血管（CV）事件的风险（临床试验注册NCT 00738179）。这项研究的结果将对世界各地的睡眠呼吸暂停患者提供医疗保健具有重要意义。SAVE研究汇集了呼吸，睡眠，CV和中风临床医生-科学家，与行业和政府赞助进行跨学科合作，进行雄心勃勃的临床试验。2008年底在澳大利亚和中国启动后，招募网络扩展到89个研究中心，包括新西兰、印度、西班牙、美国和巴西，截至2013年12月，共随机分配了2，717例患者。这些患者将随访至2015年12月，因此队列的平均随访时间将超过4年。本文描述了SAVE研究的基本原理，设计时考虑的因素，包括如何解决各种文化和伦理挑战，以及在建立和维护招募网络、患者随访以及遵守CPAP和程序方面的进展。还讨论了原始试验样本量计算的假设以及2012年下调的原因。
The Sleep Apnea cardioVascular Endpoints (SAVE) study is an ongoing investigator-initiated and conducted, international, multicenter, open, blinded endpoint, randomized controlled trial that was designed to determine whether treatment of obstructive sleep apnea (OSA) with continuous positive airways pressure (CPAP) can reduce the risk of serious cardiovascular (CV) events in patients with established CV disease (clinical trial registration NCT00738179). The results of this study will have important implications for the provision of health care to patients with sleep apnea around the world. The SAVE study has brought together respiratory, sleep, CV and stroke clinicians-scientists in an interdisciplinary collaboration with industry and government sponsorship to conduct an ambitious clinical trial. Following its launch in Australia and China in late 2008, the recruitment network expanded across 89 sites that included New Zealand, India, Spain, USA, and Brazil for a total of 2,717 patients randomized by December 2013. These patients are being followed until December 2015 so that the average length of follow-up of the cohort will be over 4 y. This article describes the rationale for the SAVE study, considerations given to the design including how various cultural and ethical challenges were addressed, and progress in establishing and maintaining the recruitment network, patient follow-up, and adherence to CPAP and procedures. The assumptions underlying the original trial sample size calculation and why this was revised downward in 2012 are also discussed.