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Sponsors and Collaborators: |
Adelaide Institute for Sleep Health Respironics ResMed Fisher and Paykel Healthcare The George Institute |
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Information provided by: | Adelaide Institute for Sleep Health |
ClinicalTrials.gov Identifier: | NCT00738179 |
OSA is a condition in which a person stops breathing for several seconds at a time due to relaxation of the throat muscles. This can occur many times over during sleep. It is known to cause sleepiness and poor concentration during the day. Research indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is CPAP. CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of SAVE is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA.
Condition | Intervention | Phase |
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Sleep Apnea Cardiovascular Disease |
Device: Continuous Positive Airway Pressure (CPAP) Other: Standard care |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 5000 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2015 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
CPAP plus Standard care of cardiovascular risk factors
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Device: Continuous Positive Airway Pressure (CPAP)
CPAP worn nightly
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2: Active Comparator
Standard care alone
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Other: Standard care
Standard care of cardiovascular risk factors
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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.
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Evidence of established coronary or cerebrovascular disease as evident by:
Coronary artery disease
Cerebrovascular disease
Exclusion Criteria:
Patients will be excluded from entry if ANY of the criteria listed below are met:
Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study. For example,
Severe respiratory disease defined as
Increased risk of a sleep-related accident and/or excessive daytime sleepiness, defined by any one of the following:
Cheyne-Stokes Respiration (CSResp)
Contact: R D McEvoy | +61 8 8275 1359 | doug.mcevoy@rgh.sa.gov.au |
Contact: S Mead | +61 8 8275 2879 | samantha.mead@rgh.sa.gov.au |
Australia, South Australia | |
Repatriation General Hospitial | |
Adelaide, South Australia, Australia, 5051 |
Principal Investigator: | R D McEvoy | Adelaide Institute for Sleep Health |
Responsible Party: | Adelaide Institute for Sleep Health ( Professor Doug McEvoy ) |
Study ID Numbers: | SAVE001 |
Study First Received: | August 19, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00738179 |
Health Authority: | Australia: Human Research Ethics Committee |
Continuous Positive Airway Pressure (CPAP) Obstructive Sleep Apnea (OSA) Cardiovascular (CV) Cardiovascular Disease Clinical Trial |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Nervous System Diseases Cardiovascular Diseases |