TY - JOUR
T1 - The Sleep Apnea cardioVascular Endpoints (SAVE) trial: Rationale, ethics, design and progress
AU - Antic, Nicholas
AU - Heeley, Emma
AU - Anderson, Craig
AU - Luo, Yuanming
AU - Wang, Jiguang
AU - Neal, Bruce
AU - Grunstein, Ron
AU - Barbe Illa, Ferran-Eduard
AU - Lorenzi-Filho, Geraldo
AU - Huang, Shao-Guang
AU - Redline, Susan
AU - Zhong, Nanshan
AU - McEvoy, Ronald
PY - 2015/8/1
Y1 - 2015/8/1
N2 - 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.
AB - 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.
KW - Cardiovascular
KW - Clinical trial
KW - OSA
KW - Outcomes
UR - http://www.scopus.com/inward/record.url?scp=84938592630&partnerID=8YFLogxK
U2 - 10.5665/sleep.4902
DO - 10.5665/sleep.4902
M3 - Article
SN - 0161-8105
VL - 38
SP - 1247
EP - 1257
JO - Sleep
JF - Sleep
IS - 8
ER -
