NCT02583906终止不适用
Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in PVR (pulmonary vascular resistance)
研究概览
简要总结
Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension) patients suffering from sleep disordered breathing.
详细描述
The primary endpoint of the study is to evaluate the effect of CPAP therapy on pulmonary vascular resistance in PAH and CTEPH patients suffering from sleep disordered breathing.
The secondary endpoints are the effect of CPAP on right atrium and right ventricle diameter and ejection fraction measured by echocardiography, 6 minutes walk distance, NYHA class, QOL, endothelial function, sympathetic activity and prognosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •minimum 18 years old
- •diagnosed with PAH or non-operable CTEPH or operated CTEPH with peristent pulmonary hypertension
- •diagnosis of PAH based on cardiac catherisation
- •diagnosis of CTEPH confirmed by contrast-enhanced spiral chest CT, pulmonary angiography and V/Q scintigraphy
- •recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before inclusion showing AHI above 15) stable clinical condition for at least 3 months before inclusion as defined by NYHA and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months
排除标准
- •congenital heart disease
- •moderate and severe restrictive or obstructive pulmonary disease with a TLC and a FEV1<60% of the predicted value
- •BMI 35kg/m2 or more
- •patients already treated with CPAP
- •patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24)
结局指标
主要结局
Change in PVR (pulmonary vascular resistance)
时间窗: change in PVR from inclusion at 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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