The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Recovery from ARAHE
研究概览
简要总结
To study whether oxygen therapy titrated to maintain oxygenation (SpO2) > 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.
详细描述
Patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. The study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Informed consent as documented by signature
- •PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
排除标准
- •resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
- •exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
- •inability to follow the procedures of the study
- •other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
结局指标
主要结局
Recovery from ARAHE
时间窗: 30 hours
Proportion of patients with precapillary pulmonary hypertension experiencing an ARAHE at 2500 m of high altitude and receiving oxygen therapy titrated to achieve SpO2 ≥ 90% who recover from ARAHE, have improved symptoms and achieve constant work-rate exercise time within a minimal important difference as defined for patients with respiratory disease within 1.75 min of baseline value at 490 m; time frame within 6 h after initiation of oxygen therapy.
次要结局
- Maximum work-rate in incremental ramp cycle exercise tests(30 hours)
- Hemodynamics(30 hours)
- Acute Mountain Sickness Score(30 hours)
- Constant work-rate exercise time(30 hours)
- Sleep disordered breathing(30 hours)
- Visual Analogue Scale(30 hours)
- sit-to-stand test(30 hours)
- Borg dyspnoea scale(30 hours)
- Cognitive testing(30 hours)
- 6 minute walk test(30 hours)