Effectiveness of the Treatment With CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 主要终点
- number of patients without diastolic dysfunction
研究概览
简要总结
The respiratory sleep disorders are a major cardiovascular risk factor. In fact there is enough scientific evidence that supports the association between apnea-hypopnea syndrome (SASH) and cardiovascular disease (hypertension, stroke, heart failure ....The objective of this study is to estimate the effectiveness of the continuous positive pressure airway (CPAP) in patient with chronic heart failure with normal ejection fraction but dyastolic dysfunction and sleep disordered breathing during the sleep.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ejection fraction> 45%, which also ruled out significant left ventricular dilation
- •At least two abnormal indices of diastolic function.
排除标准
- •Not sinus rhytm
- •Severe lung disease (FEV1 or FVC less than 50%)
- •Significant valvular or congenital heart disease, primary
- •Unstable angina, myocardial infarction or cardiac surgery within three months prior to inclusion
- •Hypertrophic Cardiomyopathy
- •Presence of significant psychiatric disorders.
- •Severe Hypersomnia . (Epworth> 20)
- •Severe pulmonary hypertension measured by Doppler,
- •Facial deformity and / or defect of nasal patency.
结局指标
主要结局
number of patients without diastolic dysfunction
时间窗: One year
number of patient without diastolic dysfunction defined by any of this parametres: TRI (isovolumetric relaxation time):\> 105 ms (\> 50 years),\> 100 ms (30-50 years). 2. Wave ratio E / A wave \<1 and deceleration time\> 220 ms (under 50) and E / A \<0.5 and deceleration time\> 280 ms (50 +). 3. Relationship between systolic and diastolic wave flow following pulmonary vein (S / D): S / D\> 1.5 (under 50) and S / D\> 2.5 (over 50). A wave velocity of pulmonary venous flow\> 35 cm / s. Flow propagation velocity by color M-mode \<45 cm / s. E wave peak velocity by DTI of the ring: Em \<5 cm / s
number of hospital admissions for any cause
时间窗: One year
次要结局
未报告次要终点