NCT05131737已完成不适用
The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
适应症
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
- cycle constant work-rate exercise test
研究概览
简要总结
The impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension
详细描述
Patients with pulmonary hypertension will perform a constant work-rate exercise test at low altitude (450m) and at high altitude 2500m in a randomized-cross-over sequence protocol. The constant work-rate exercise test time and other measures will be assessed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 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
cycle constant work-rate exercise test
时间窗: 30 hours
Difference in cycle constant work-rate exercise test (CWRET) time at 2500 vs. 490 m (Time Frame 24 to 30 hours)
次要结局
- Oxygen uptake(30 hours)
- Visual analogue scale(30 hours)
- sit-to-stand test frequency(30 hours)
- Heart rate(30 hours)
- Ventilation in liters per minute(30 hours)
- Oxygen saturation(30 hours)
- Partial pressure or oxygen(30 hours)
- Borg dyspnoea scale(30 hours)
- Tricuspid pressure gradient(30 hours)
- 6 minute walk test(30 hours)
研究者
研究点 (2)
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