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临床试验/NCT07804693
NCT07804693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:
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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 re-ascent to 2850m
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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 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 re-ascent (sea level for 7 days vs. re-ascent to 2850m) 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 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)

研究组 & 干预措施

Pulmonary resistance (sPAP/CO) at sea level and after re-ascent at 2850m

Experimental

Assessment of pulmonary resistance (sPAP/CO) and other hemodynamic parameters after 7 days at sea level with re-ascent from sea level back to 2850m by bus (in one day) and assessment of the same outcomes

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 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 patients with pulmonary arterial hypertension

次要结局

  • Tricuspid regurgitation velocity TRV after re-ascent to 2850m(From Day 5-7 at sea level to 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

发起方
Silvia Ulrich Somaini
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Silvia Ulrich Somaini

Prof. Dr. med.

University of Zurich

研究点 (1)

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