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
- Cognitive Function test
研究概览
简要总结
Randomized crossover Trial in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to High Altitude (2500m above sea level) on cognitive functions
详细描述
Low altitude baseline measurements will be performed in Zurich (460m) including Echocardiography, Right heart catheterization, 6 Minute walk test, 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).
During the exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hour, the participants will perform cognitive function test .
The results will be compared to low altitude in Zurich (470m).
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: mPAP ≥ 25 mmHg along with a 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 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 kPa)
- •Susceptibility to high altitude related diseases (AMS, 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
Cognitive Function test
时间窗: 1 day at altitude
Change in cognitive function test time during the exposure to High altitude (Säntis ; 2500m above sea level) compared to low altitude (Zurich)
次要结局
未报告次要终点