Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Patients With Pulmonary Arterial Hypertension PAH
2026年8月31日 更新者：Silvia Ulrich Somaini
Effect of a One-week Descent From 2850m to Sea Level and Re-ascent in Patients With Pulmonary Arterial Hypertension and Healthy Controls Permanently Living > 2600m on Pulmonary Hemodynamics, Exercise Capacity, Blood Oxygenation, Sleep Disordered Breathing and Further Outcomes
To study the effect of a re-ascent to high altitude (Quito Ecuador: 2850m) after a one-week stay at sea level (after prior descent from 2850m) on lung function and pulmonary resistance/reactance in patients with pulmonary arterial disease PAH, who live permanently > 2600m.
研究概览
详细说明
The aim of this research is to investigate the lung function and pulmonary resistance/reactance before and after re-ascent (sea level for 7 days after prior descent from 2850m vs. re-ascent to 2850m) in patients with diagnosed pulmonary hypertension according to guidelines, who permanently live at high altitude over 2600m.
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Silvia Ulrich, Prof. Dr. med.
- 电话号码：+41442552220
- 邮箱：silvia.ulrich@usz.ch
研究联系人备份
- 姓名：Michael Furian, Prof. Dr. sc. ETH
- 电话号码：+41442552220
学习地点
-
-
-
Zurich、瑞士、8091
- University Hospital of Zurich
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adult patients aged 18-80 years and of all genders
- Permanent residence > 2600 m
- Diagnosis of pulmonary arterial hypertension PAH (PAHHA-Group) according to guidelines
- Patients are stable on therapy
- NYHA (new york heart association) functional class I-III.
- written informed consent to participate in the study.
Exclusion Criteria:
- Age <18 years or >80 years
- unstable condition
- Patients who cannot follow the study investigations
- Patient permanently living < 2600m.
- Patients who traveled and stayed overnight at altitudes <2000 m in the past 4 weeks.
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
- Severely hypoxemic patients at Quito permanently having persistent SpO2 (oxygen saturation by pulseoximetry) <80% on ambient air.
- Patient with a non-corrected ventricular septum defect
- Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Lung function at sea level and at 2850m
Assessment of lung function and pulmonary resistance/reactance on day four at sea level (after prior descent from 2850m) and after re-ascent (after totally one week at sea level) back to 2850m by bus (in one day)
|
Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back to their usual living altitude at 2850m
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
FEV1 after re-ascent to 2850m
大体时间：From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
Difference/change in forced expiratory volume in one second FEV1 between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Forced Vital Capacity FVC after re-ascent to 2850m
大体时间：From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
Difference/change in forced vital capacity FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
|
FEV1/FVC after re-ascent to 2850m
大体时间：From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
Difference/change in FEV1/FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
|
Respiratory Impedance (forced oscillation technique) after re-ascent to 2850m
大体时间：From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
Difference/change in respiratory impedance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
|
Respiratory resistance (forced oscillation technique) after re-ascent to 2850m
大体时间：From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
Difference/change in respiratory resistance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
|
Respiratory reactance (forced oscillation technique) after re-ascent to 2850m
大体时间：From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
Difference/change in respiratory reactance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
|
FEV1 after 4 days at sea level
大体时间：From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in FEV1 between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
Forced Vital Capacity FVC after 4 days at sea level
大体时间：From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in forced vital capacity FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
FEV1/FVC after 4 days at sea level
大体时间：From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in FEV1/FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
Respiratory Impedance (forced oscillation technique) after 4 days at sea level
大体时间：From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in respiratory impedance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
Respiratory resistance (forced oscillation technique) after 4 days at sea level
大体时间：From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in respiratory resistance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
Respiratory reactance (forced oscillation technique) after 4 days at sea level
大体时间：From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in respiratory reactance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
FEV1 pre-descent and after re-ascent (2850m)
大体时间：Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in FEV1 at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial disease
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Forced Vital Capacity FVC pre-descent and after re-ascent (2850m)
大体时间：Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in forced vital capacity FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
FEV1/FVC pre-descent and after re-ascent (2850m)
大体时间：Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in FEV1/FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory Impedance (forced oscillation technique) pre-descent and after re-ascent (2850m)
大体时间：Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory impedance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory resistance (forced oscillation technique) pre-descent and after re-ascent (2850m)
大体时间：Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory resistance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory reactance (forced oscillation technique) pre-descent and after re-ascent (2850m)
大体时间：Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory reactance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Silvia Ulrich、University Hospital Zurich, Departement of Pulmonology
- 首席研究员：Rodrigo Hoyos、Hospital Carlos Andrade Marin of Quito, Ecuador
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月25日
初级完成 (估计的)
2026年10月4日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2026年8月17日
首先提交符合 QC 标准的
2026年8月31日
首次发布 (实际的)
2026年9月4日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年8月31日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- Ec_LAvsHA_Lufu_PAH
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.