Comparison of Adaptive Servo Ventilation(Bipap® Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction confirmed by echocardiography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Left ventricular ejection fraction confirmed by echocardiography
时间窗: three months
次要结局
- 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)
研究者
Kimihiko Murase
medical doctor
Kyoto University, Graduate School of Medicine