Comparison of Adaptive Servo Ventilation(Bipap® Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure
- Sponsor
- Kyoto University, Graduate School of Medicine
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Left ventricular ejection fraction confirmed by echocardiography
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep apnea.
Detailed Description
Central sleep apnea(CSA) is associated with chronic heart failure(CHF). At present, both of nocturnal oxygen therapy and adaptive servo ventilation(ASV) are recognized as effective modalities. However,in fact, majority of CHF patients are complicated not only with CSA but with obstructive sleep apnea(OSA). Recently, Philips developed Bipap® auto SV Advanced for such patients. It has auto-CPAP function as the modality of OSAS, in addition to ASV function. The present study is prospective randomised study to compare the effects of nocturnal oxygen therapy and Bipap® auto SV Advanced.
Investigators
Kimihiko Murase
medical doctor
Kyoto University, Graduate School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Left ventricular ejection fraction\<50% confirmed by echocardiography
- •Apnea hypopnea index(AHI)\>=20 confirmed by overnight polysomnography
- •More than 15% of AHI is due to CSA
Exclusion Criteria
- •Changes of cardioactive drug prescriptions within 6 weeks
- •Admission due to cardiovascular events within 6 weeks
- •Ever used CPAP or ASV for sleep apnea
- •Ever used nocturnal oxgen therapy
- •Subjects with acute exacerbation of chronic heart failure
- •Operation for upper airway within 90 days
- •Renal dialysis
- •History of stroke with neurological deficit
Outcomes
Primary Outcomes
Left ventricular ejection fraction confirmed by echocardiography
Time Frame: three months
Secondary Outcomes
- Blood pressure(three months)
- Heart rate(three months)
- Urinary biomarkers(three months)
- Serum biomarkers(three months)
- Sleep quality confirmed by polysomnography(three months)
- Endothelial function(three months)
- Sleepiness(three months)
- health-related quality of life(three months)