SAVE
Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease
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Status:
This study is open and recruiting patients.
Purpose:
To determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA.
Location(s):
Australia, South Australia
Year Started:
2009
Design:
Interventional, Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study.
Inclusion Criteria
Evidence of established coronary or cerebrovascular disease as evident by: Coronary artery disease; previous MI (equal to or greater than 90 days prior to informed consent);
stable angina or unstable angina (equal to or greater than 30 days prior to informed consent) each with documented multi-vessel coronary artery disease or 50% or more stenosis in at least two major coronary arteries on coronary angiography, or positive stress test (ST depression equal to or greater than 2 mm or a positive nuclear perfusion scintigram); multi-vessel percutaneous angioplasty (PTCA) and/or stent equal to or greater than 90 days prior to informed consent; multi-vessel coronary artery bypass surgery (CABG) >1 year prior to informed consent; cerebrovascular disease. Previous stroke (includes definite or presumed cerebral ischaemia/infarction and intracerebral haemorrhage) equal to or greater than 90 days prior to informed consent; previous transient ischaemic event (TIA) of the brain or retina (symptoms <24 hours) with the diagnosis confirmed by a neurologist 30 days to I year prior to informed consent; patients have moderate-severe OSA (equivalent to apnea plus hypopneas index [AHI] >30 per hour of sleep) as determined by a > 4% oxygen dip rate > 12/ h on overnight testing using the ApneaLinkTM device and confirmed by the SAVE core lab in Adelaide upon receipt of the ApneaLink data.
Exclusion Criteria
Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study. For example, co-morbid disease with severe disability or likelihood of death within the next 2 years; significant memory, perceptual, or behavioural disorder; neurological deficit (eg. limb paresis) preventing self administration of the CPAP mask; residence sufficiently remote from the clinic to preclude follow-up clinic visits;
any planned coronary or carotid revascularisation procedure in the next 6 months; severe respiratory disease defined as
severe chronic obstructive pulmonary disease (FEV1/FVC < 70% and FEV1 < 50% predicted), or resting, awake SaO2 < 90% by ApneaLinkTM device; New York Heart Association (NYHA) categories III-IV of heart failure; stroke due to subarachnoid haemorrhage; other household member enrolled in SAVE trial or using CPAP; prior use of CPAP treatment for OSA; increased risk of a sleep-related accident and/or excessive daytime sleepiness, defined by any one of the following: driver occupation (eg truck, taxi,), 'fall-asleep' accident or 'near miss' accident in previous 12 months, high (> 15) score on the Epworth Sleepiness Scale,
severe nocturnal desaturation documented on the ApneaLinkTM device as > 10% overnight recording time with arterial oxygen saturation of < 80%; Cheyne-Stokes Respiration (CSResp); CSResp identified on ApneaLinkTM nasal pressure recording by typical crescendo-decrescendo pattern of respiration with associated apneas and/or hypopneas in the absence of inspiratory flow limitation; patients excluded if > 50% of nasal pressure - defined apneas and hypopneas judged to be due to CSResp.
Patient Involvement:
Anesthetic for surgery - local versus general. Randomization will be by telephone to the trial office. Data will be collected at baseline (prior to randomization) and this will include demographic details, known risk factors, diagnostic procedures and findings, and indications for surgery. The follow-up data will be collected when the patient is discharged from acute care, and operative details and any early complications will be recorded. At 1 month post-surgery, a stroke physician, blind to the type of anesthesia, will review the patient. Also the patient will be asked to complete a health related quality of life questionnaire including the widely used EuroQol and Short Form 36, plus a carotid endarterectomy (CEA) specific questionnaire designed to capture patient satisfaction levels with the method of anaesthesia. Length of time spent in the recovery room, intensive care unit (ICU) and high dependency unit (HDU), and length of overall acute hospital stay will be recorded. Annual follow up will be by post to the family doctor and to the patient, seeking details of any strokes.
Primary Outcome:
A composite of the CV endpoints of CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisation for unstable angina or transient ischaemic attack
Secondary Outcome:
Composite of CV death, MI & ischaemic stroke; components of primary composite endpoint; re-vascularisation procedures; all-cause death; new onset atrial fibrillation; new onset diabetes; OSA symptom scores; mood; health-related quality of life; in a sub-sample of 600 subjects pathophysiological mechanisms of CPAP-induced CV event reduction will be explored by assessing various intermediate markers of CV risk
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 10/5/2009
Reviewed on: 07/07/2009.
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