Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Echocardiographic assessment at High Altitude (2500m above sea level)
研究概览
简要总结
Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude ("Säntis"; 2500m above sea level) on pulmonary artery pressure and right heart function (echo)
详细描述
Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis.
Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).
Several times within the exposure, the pulmonary artery pressure (PAP) and the right heart function will be assessed by echo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Informed consent
- •PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
- •PH class 1 (PAH) or 4 (CTEPH)
- •Stable condition, on the same medication for > 4 weeks
- •Patient live permanently at an altitude < 1000m asl.
排除标准
- •Resting partial Oxygen pressure (PaO2) ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed)
- •Severe daytime hypercapnia (pCO2 > 6.5 kilopascal (kPa))
- •Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
- •Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation
- •Residence > 1000m above sea level
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
- •Women who are pregnant or breast feeding
结局指标
主要结局
Echocardiographic assessment at High Altitude (2500m above sea level)
时间窗: 1 day at altitude
Pulmonary artery pressure will be measured by echo (TTE).
次要结局
- Echocardiographic right heart assessment at High Altitude (2500m above sea level)(1 day at altitude)