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
- arterial blood oxygenation under simulated altitude at rest (FiO2: 15.1)
研究概览
简要总结
Randomized crossover trial in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on blood and tissue oxygenation (ABGA, near infrared spectroscopy)
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 under simulated altitude (FiO2: 15.1% with the "AMC altitrainer") and shamed altitude with the same device.
At rest and under exercise data from ABGA and near infrared spectroscopy will be compared under simulated altitude and shamed altitude.
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
- Single (Participant)
盲法说明
The allocated gas mixture will not be disclosed to the patient since he will breath through a facemask during both interventions.
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 kilopascal (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, 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
arterial blood oxygenation under simulated altitude at rest (FiO2: 15.1)
时间窗: 2 hours
Difference in arterial blood oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at rest.
arterial blood oxygenation under simulated altitude at the time of exhaustion (FiO2: 15.1)
时间窗: 2 hours
Difference in arterial blood oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at the time of exhaustion
次要结局
- Near infrared spectroscopy under simulated altitude at rest (FiO2: 15.1)(2 hours)