The Sleep Apnea cardioVascular Endpoints (SAVE) Trial: Rationale, Ethics, Design, and Progress

被引：43

作者：

Antic, Nick A. ^{[1
,2
]}

Heeley, Emma ^{[2
,3
]}

Anderson, Craig S. ^{[2
,3
,4
]}

Luo, Yuanming ^{[5
]}

Wang, Jiguang ^{[6
]}

Neal, Bruce ^{[2
,3
,4
,7
]}

Grunstein, Ron ^{[4
,8
]}

Barbe, Ferran ^{[9
]}

Lorenzi-Filho, Geraldo ^{[10
]}

Huang, Shaoguang ^{[11
]}

Redline, Susan ^{[12
,13
,14
]}

Zhong, Nanshan ^{[5
]}

McEvoy, R. Doug ^{[1
,2
]}

机构：

[1] Repatriat Gen Hosp, Adelaide Inst Sleep Hlth, Daw Pk, SA 5000, Australia

[2] Flinders Univ S Australia, Fac Med Nursing & Hlth Sci, Sch Med, Bedford Pk, SA 5042, Australia

[3] Univ Sydney, George Inst Global Hlth, Sydney, NSW 2006, Australia

[4] Royal Prince Alfred Hosp, Camperdown, NSW 2050, Australia

[5] Guangzhou Med Univ, Affiliated Hosp 1, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R China

[6] Ruijin Hosp, Shanghai Inst Hypertens, Shanghai, Peoples R China

[7] Univ London Imperial Coll Sci Technol & Med, London, England

[8] Univ Sydney, Ctr Integrated Res & Understanding Sleep, Woolcock Inst Med Res, Sydney, NSW 2006, Australia

[9] Univ Lleida Barcelona, Sch Med, Barcelona, Spain

[10] Univ Sao Paulo, Heart Inst InCor, Div Pulm, BR-05508 Sao Paulo, Brazil

[11] Shanghai Rui Jin Hosp, Shanghai, Peoples R China

[12] Brigham & Womens Hosp, Dept Med, Boston, MA 02115 USA

[13] Brigham & Womens Hosp, Div Sleep, Boston, MA 02115 USA

[14] Beth Israel Deaconess Med Ctr, Boston, MA USA

来源：

SLEEP | 2015年 / 38卷 / 08期

基金：

澳大利亚研究理事会; 英国医学研究理事会; 澳大利亚国家健康与医学研究理事会;

关键词：

OSA; cardiovascular; outcomes; clinical trial; POSITIVE AIRWAY PRESSURE; BLOOD-PRESSURE; RISK-FACTOR; INTERMITTENT HYPOXIA; FOLLOW-UP; DISEASE; ASSOCIATION; STROKE; MORTALITY; EVENTS;

D O I：

10.5665/sleep.4902

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

100204 [神经病学];

摘要：

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.

引用

页码：1247 / 1257

页数：11

共 63 条

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Statistical analysis plan for the second INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2): a large-scale investigation to solve longstanding controversy over the most appropriate management of elevated blood pressure in the hyperacute phase of intracerebral hemorrhage [J].