deltatrials
Unknown PHASE3 INTERVENTIONAL 2-arm NCT00738179

Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease (SAVE)

Sleep Apnea cardioVascular Endpoints Study - Investigating the Effectiveness of Treatment With CPAP vs Standard Care in Reducing CV Morbidity and Mortality in Patients With Co-existing CV Disease and Moderate-severe Obstructive Sleep Apnea.

Sponsor: Adelaide Institute for Sleep Health

Updated 7 times since 2017 Last updated: Feb 4, 2015 Started: Sep 30, 2008 Primary completion: Dec 31, 2015 Completion: Dec 31, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00738179, this PHASE3 trial focuses on Cardiovascular Disease and Sleep Apnea and remains ongoing. Sponsored by Adelaide Institute for Sleep Health, it has been updated 7 times since 2008, reflecting limited change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Study Description(click to expand)

There is increasing evidence to indicate that OSA is an important modifiable risk factor for CV disease including stroke, MI, and heart failure. Increased nocturnal arterial blood pressure (BP), hypercoagulability, oxidative stress, inflammation, insulin resistance and cardiac arrhythmias are all associated with OSA. These effects are presumed to accelerate the progression of atheromatous disease, particularly within the coronary or cerebral vasculature. Moreover, OSA also appears to increase the risk of sudden death during sleep, which is different from the circadian pattern of sudden death in those without OSA, suggesting that episodes of apnea may have a direct triggering effect for cardiac arrhythmias or MI. CPAP is now standard therapy for symptomatic OSA, with adherence to treatment comparable to that of other therapies for common chronic diseases. CPAP can eliminate apneas and improve daytime sleepiness, mood and quality of life. Furthermore, short term (1-3 months) randomised controlled trials of CPAP have shown modest reductions in blood pressure (BP) and other markers of CV disease, including C-reactive protein (CRP) and coagulation. However, the epidemiological data is complicated by potential residual confounding factors and the randomised evidence is limited. Thus, a direct causal link between OSA and CV disease remains inconclusive. The management...

There is increasing evidence to indicate that OSA is an important modifiable risk factor for CV disease including stroke, MI, and heart failure. Increased nocturnal arterial blood pressure (BP), hypercoagulability, oxidative stress, inflammation, insulin resistance and cardiac arrhythmias are all associated with OSA. These effects are presumed to accelerate the progression of atheromatous disease, particularly within the coronary or cerebral vasculature. Moreover, OSA also appears to increase the risk of sudden death during sleep, which is different from the circadian pattern of sudden death in those without OSA, suggesting that episodes of apnea may have a direct triggering effect for cardiac arrhythmias or MI.

CPAP is now standard therapy for symptomatic OSA, with adherence to treatment comparable to that of other therapies for common chronic diseases. CPAP can eliminate apneas and improve daytime sleepiness, mood and quality of life. Furthermore, short term (1-3 months) randomised controlled trials of CPAP have shown modest reductions in blood pressure (BP) and other markers of CV disease, including C-reactive protein (CRP) and coagulation. However, the epidemiological data is complicated by potential residual confounding factors and the randomised evidence is limited. Thus, a direct causal link between OSA and CV disease remains inconclusive. The management of OSA, therefore, remains principally directed towards symptom control rather than CV risk modification.

The present trial aims to test whether long-term use of CPAP can reduce the incidence of CV events. If the trial shows that CPAP treatment of OSA reduces the incidence of CV events it will influence clinical practice toward the early detection and management of OSA, and add CPAP to the range of strategies available for the prevention of CV disease.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE3

  2. Sep 2024 — Present [monthly]

    Unknown PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE3

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Unknown Status PHASE3

    Status: Active Not RecruitingUnknown Status

  2. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Sep 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Adelaide Institute for Sleep Health
  • Fisher and Paykel Healthcare
  • Health Research Council, New Zealand
  • National Health and Medical Research Council, Australia
  • Philips Respironics
  • ResMed
  • The George Institute
Data source: Adelaide Institute for Sleep Health

For direct contact, visit the study record on ClinicalTrials.gov .