NCT07804524尚未招募不适用
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
Silvia Ulrich Somaini1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年9月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pulmonary resistance (sPAP/CO) after 7 days at sea level
研究概览
简要总结
To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes in patients with pulmonary arterial hypertension PAH, who live permanently >2600m.
详细描述
The aim of this research is to investigate the pulmonary resistance (sPAP/CO) by echocardiography and other hemodynamic outcomes before and after relocation (high altitude near their living altitude vs. sea level) in patients with diagnosed pulmonary arterial hypertension according to guidelines, who permanently live at high altitude over 2600m.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 2850m 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)
研究组 & 干预措施
Pulmonary resistance (sPAP/CO) at 2850m and at sea level
Experimental
Measurement of pulmonary resistance (sPAP/CO) by echocardiography and other hemodynamic parameters near their resident altitude at 2850m followed by a descent from 2850m to sea level by bus with a stay for 7 days and again measurements by echocardiography
干预措施: Descent from 2850m to sea level (Behavioral)
结局指标
主要结局
Pulmonary resistance (sPAP/CO) after 7 days at sea level
时间窗: From high altitude (2850m) to day 5-7 at sea level
Difference in sPAP/CO by echocardiography between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension
次要结局
- Tricuspid regurgitation velocity TRV after 7 days at sea level(From high altitude (2850m) to day 5-7 at sea level)
- Cardiac output CO after 7 days at sea level(From high altitude (2850) to day 5-7 at sea level)
- Tricuspid annular plan systolic excursion TAPSE after 7 days at sea level(From high altitude (2850m) to day 5-7 at sea level)
- Right ventricular strain after 7 days at sea level(From high altitude (2850m) to Day 5-7 at sea level)
- Right atrial pressure RAP after 7 days at sea level(From high altitude (2850m) to Day 5-7 at sea level)
- Fractional area change FAC after 7 days at sea level(From high altitude (2850m) to Day 5-7 at sea level)
- PaO2 after 7 days at sea level(From high altitude (2850) to day 5-7 at sea level)
- PaCO2 after 7 days at sea level(From high altitude (2850) to day 5-7 at sea level)
- Hemoglobin after 7 days at sea level(From high altitude (2850) to day 5-7 at sea level)
- pH after 7 days at sea level(From high altitude (2850) to day 5-7 at sea level)
- Acclimatization-Effect of pulmonary resistance (sPAP/CO) at sea level(From Day 2 to Day 5-7 at sea level)
- Acclimatization-Effect of tricuspid regurgitation velocity TRV at sea level(From Day 2 to Day 5-7 at sea level)
- Acclimatization-Effect of cardiac output CO at sea level(From Day 2 to Day 5-7 at sea level)
- Acclimatization-Effect of tricuspid annular plan systolic excursion TAPSE at sea level(From Day 2 to day 5-7 at sea level)
- Acclimatization-Effect of right ventricular strain at sea level(From Day 2 to Day 5-7 at sea level)
- Acclimatization-Effect of right atrial pressure RAP at sea level(From Day 2 to Day 5-7 at sea level)
- Acclimatization-Effect of fractional area change FAC at sea level(From Day 2 to Day 5-7 at sea level)
- Acclimatization-Effect of PaO2 at sea level(From Day 2 to Day 7 at sea level)
- Acclimatization-Effect of PaCO2 at sea level(From Day 2 to Day 7 at sea level)
- Acclimatization-Effect of hemoglobin at sea level(From Day 2 to Day 7 at sea level)
- Acclimatization-Effect of pH at sea level(From Day 2 to Day 7 at sea level)
研究者
Silvia Ulrich Somaini
Prof. Dr. med.
University of Zurich
研究点 (1)
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