The Sleep Apnea cardioVascular Endpoints (SAVE) trial: Rationale, ethics, design and progress

Nicholas Antic, Emma Heeley, Craig Anderson, Yuanming Luo, Jiguang Wang, Bruce Neal, Ron Grunstein, Ferran-Eduard Barbe Illa, Geraldo Lorenzi-Filho, Shao-Guang Huang, Susan Redline, Nanshan Zhong, Ronald McEvoy

    Research output: Contribution to journalArticlepeer-review

    23 Citations (Scopus)

    Abstract

    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.

    Original languageEnglish
    Pages (from-to)1247-1257
    Number of pages11
    JournalSleep
    Volume38
    Issue number8
    DOIs
    Publication statusPublished - 1 Aug 2015

    Keywords

    • Cardiovascular
    • Clinical trial
    • OSA
    • Outcomes

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