NCT07804589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 14 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
- 14
- 试验地点
- 1
- 主要终点
- Pulmonary resistance (sPAP/CO) after re-ascent to 2850m
研究概览
简要总结
To study the effect of a re-ascent after a one-week stay at sea level (after prior descent from 2850m) to high altitude (Quito Ecuador: 2850m) on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes in healthy individuals, 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 re-ascent (sea level for 7 days vs. re-ascent to 2850m) in healthy individuals, 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
- 是
入选标准
- •Adults aged 18-80 years and of all genders
- •Permanent residence > 2600 m.
- •healthy: no self-perceived cardiopulmonary disease limiting daily activities
- •written informed consent to participate in the study.
排除标准
- •Age <18 years or >80 years
- •Participants who cannot follow the study investigations
- •Participants permanently living < 2600m.
- •Participants who traveled and stayed overnight at altitudes <2000 m in the past 4 weeks.
- •any self-perceived cardiopulmonary disease limiting daily activities
研究组 & 干预措施
Pulmonary resistance (sPAP/CO) at sea level and 2850m
Experimental
Assessment of pulmonary resistance (sPAP/CO) and other hemodynamic outcomes after 7 days at sea level and after re-ascent at 2850m
干预措施: Re-Ascent from sea level to 2850m (Behavioral)
结局指标
主要结局
Pulmonary resistance (sPAP/CO) after re-ascent to 2850m
时间窗: From Day 5-7 at sea level to the day after re-ascent
Difference in sPAP/CO by echocardiography between sea level (after one-week stay) and day after re-ascent at 2850m in healthy individuals
次要结局
- Tricuspid regurgitation velocity TRV after re-ascent to 2850m(From Day 5-7 at sea level to the day after re-ascent)
- Cardiac output CO after re-ascent to 2850m(From Day 5-7 at sea level to the day after re-ascent)
- Tricuspid annular plan systolic excursion TAPSE after re-ascent to 2850m(From Day 5-7 at sea level to day after re-ascent)
- Right ventricular strain after re-ascent to 2850m(From Day 5-7 at sea level to day after re-ascent)
- Right atrial pressure RAP after re-ascent to 2850m(From Day 5-7 at sea level to day after re-ascent)
- Fractional area change FAC after re-ascent to 2850m(From Day 5-7 at sea level to day after re-ascent)
- PaO2 after re-ascent to 2850m(From Day 7 at sea level to day after re-ascent (time frame of 3 days))
- PaCO2 after re-ascent to 2850m(From Day 7 at sea level to day after re-ascent (time frame of 3 days))
- Hemoglobin after re-ascent to 2850m(From Day 7 at sea level to day after re-ascent (time frame of 3 days))
- pH after re-ascent to 2850m(From Day 7 at sea level to day after re-ascent (time frame of 3 days))
- Pulmonary resistance (sPAP/CO) pre-descent to after re-ascent(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))
- Tricuspid regurgitation velocity TRV pre-descent to after re-ascent(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))
- Cardiac output CO pre-descent to after re-ascent(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))
- Tricuspid annular plan systolic excursion TAPSE pre-descent to after re-ascent(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))
- Right ventricular strain pre-descent to after re-ascent(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))
- Right atrial pressure RAP pre-descent to after re-ascent(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))
- Fractional area change FAC pre-descent to after re-ascent(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))
- PaO2 pre-descent to after re-ascent(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))
- PaCO2 pre-descent to after re-ascent(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))
- Hemoglobin pre-descent to after re-ascent(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))
- pH pre-descent to after re-ascent(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))
研究者
Silvia Ulrich Somaini
Prof. Dr. med.
University of Zurich
研究点 (1)
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