SAVE (Sleep Apnea cardioVascular Endpoints) studyAn international, multi-centre, open, parallel group, prospective, randomised, controlled trial to determine the effectiveness of treatment with continuous positive airways pressure (CPAP) in addition to standard care in reducing cardiovascular (CV) morbidity and mortality in patients with co-existing CV disease and moderate-severe obstructive sleep apnea (OSA).

Respironics Sleep and Respiratory Research Foundation0 sites2,500 target enrollmentAugust 20, 2008

ConditionsObstructive Sleep Apnea Cardiovascular Disease Respiratory - Sleep apnoea Cardiovascular - Coronary heart disease Cardiovascular - Other cardiovascular diseases

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Obstructive Sleep Apnea
Sponsor: Respironics Sleep and Respiratory Research Foundation
Enrollment: 2500
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 20, 2008

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Respironics Sleep and Respiratory Research Foundation

Eligibility Criteria

Inclusion Criteria

•1\. Males and females, any race, and aged between 45 and 75 years
•2\. Evidence of established coronary or cerebrovascular disease as evident by;
•(a) Coronary artery disease.
•i. Previous MI (greater than or equal to 90 days prior to ApneaLinkTM assessment); or
•ii. Stable angina or unstable angina (Clinical event greater than or equal to 30 days and confirmatory test equal to or greater than 7 days prior to ApneaLinkTM assessment) defined as either greater than or equal to 70% diameter stenosis of at least one major epicardial artery segment, or greater than or equal to 50% diameter stenosis of the left main coronary artery, or greater than 50% stenosis in at least two major epicardial arteries, or positive stress test (ST depression greater than or equal to 2 mm or a positive nuclear perfusion scintigram); or
•iii. Multi\-vessel percutaneous angioplasty (PTCA) and/or stent greater than or equal to 90 days prior to ApneaLinkTM assessment; or
•iv. Multi\-vessel coronary artery bypass surgery (CABG) greater than 1 year prior to ApneaLinkTM assessment
•(b) Cerebrovascular disease
•i. Previous stroke (includes definite or presumed cerebral ischaemia/infarction and intracerebral but not subarachnoid haemorrhage) greater than or equal to 90 days prior to ApneaLinkTM assessment; or or minor disabling stroke with minimal residual neurological disability (modified Rankin Score of ‘0 equal to no symptoms’ or ‘1 equal to No significant disability despite symptoms, able to carry out all usual duties and activities’ within 7 days of stroke onset) greater than or equal to 7 days prior to ApneaLinkTM assessment; or
•ii. Previous transient ischaemic event (TIA) of the brain or retina (symptoms less than 24 hours) but not of presumed vertebrobasilar system ischemia. The TIA diagnosis must be confirmed by a suitably qualified clinician (greater than or equal to 7 days but less than 1 year prior to ApneaLinkTM assessment)

Exclusion Criteria

•Patients will be excluded from entry if ANY of the criteria listed below are met:
•1\. Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study. For example,
•i. co\-morbid disease with severe disability or likelihood of death
•ii. significant memory, perceptual, or behavioural disorder
•iii. neurological deficit (eg. limb paresis) preventing self administration of the CPAP mask
•iv. contraindication to CPAP use e.g. pneumothoraxv residence sufficiently remote from the clinic to preclude follow\-up clinic visits
•2\. Any planned coronary or carotid revascularisation procedure in the next 6 months
•3\. Severe respiratory disease defined as
•i. severe chronic obstructive pulmonary disease (FEV1/FVC greater than 70% and FEV1 less than 50% predicted), or
•ii. resting, awake SaO2 less than 90% by ApneaLinkTM device