NCT05264324已完成不适用
The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Maximal work rate
研究概览
简要总结
The impact of hypoxia on maximal work rate during incremental ramp exercise within 3-6 hours after arriving at 2500m of high altitude in patients with precapillary pulmonary hypertension
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 as documented by signature (Appendix Informed Consent Form)
- •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)
研究组 & 干预措施
High altitude 2500 m above sea level (high altitude)
Experimental
Maximum Exercise Capacity in high altitude
干预措施: Maximal Exercise Capacity (Procedure)
Low altitude 470 m above sea level (low altitude)
Active Comparator
Maximum Exercise Capacity in low altitude
干预措施: Maximal Exercise Capacity (Procedure)
结局指标
主要结局
Maximal work rate
时间窗: 30 hours
Change in maximal work rate in Watt at 2500 vs. 490 m
次要结局
- Electro cardiography: QT-Interval(30 hours)
- Rate pressure product(30 hours)
- Electro cardiography: Clinically relevant ischemia(30 hour)
- Electro cardiography: PQ-Interval(30 hours)
- Heart rate(30 hours)
- Ventilation(30 hours)
- Electro cardiography(30 hours)
- Electro cardiography: ST-segment changes under oxygen(30 hours)
- Oxygen uptake(30 hours)
- Arterial blood oxygenation saturation(30 hours)
- Blood gases(30 hours)
- Borg dyspnoea and leg fatigue scale(30 hours)
- Electro cardiography :ST-segment changes(30 hours)
- Hemodynamics(30 hours)
- Visual Analogue Scale for dyspnea(30 hours)
- Electro cardiography: Cardiac arrhythmia(30 hours)
研究者
研究点 (1)
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