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Assessment of Heart Rate Variability HRV During Descent DE From 2850m to Sea Level and During Re-ascent A From Sea Level to 2850m in Healthy Individuals H

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 relocation from high altitude (Quito Ecuador: 2850m) to sea level and re-ascent from sea level to 2850m on heart rate variability and other hemodynamic parameters in healthy individuals, who live permanently >2600m.

研究概览

详细说明

The aim of this research is to investigate the heart rate variability and other hemodynamic outcomes during the descent from 2850m to sea level and during re-ascent from sea level to 2850m in healthy individuals, who permanently live at high altitude over 2600m

研究类型

介入性

注册 (估计的)

14

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

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

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

是的

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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:Heart rate variability HRV during descent and re-ascent
Assessment of heart rate variability and other hemodynamic outcomes in healthy individuals during descent from 2850m to sea level and during re-ascent from sea level (after one week stay) back to their living altitude at 2850m
Descent from 2850m to sea level (in one day by bus) and re-ascent after 7 days from sea level to 2850m (in one day by bus)

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
Heart rate variability HRV during descent and re-ascent
大体时间:From day of descent (day 1) and day of re-ascent (day 8)
Difference/change in heart rate variability at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in healthy individuals
From day of descent (day 1) and day of re-ascent (day 8)

次要结果测量

结果测量
措施说明
大体时间
SpO2 during descent and re-ascent
大体时间:From day of descent (day 1) and day of re-ascent (day 8)
Difference/change in SpO2 at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in healthy individuals
From day of descent (day 1) and day of re-ascent (day 8)
ECG-Repolarization during descent and re-ascent
大体时间:From day of descent (day 1) and day of re-ascent (day 8)
Occurrence/changes in cardial arrhythmias at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in healthy individuals
From day of descent (day 1) and day of re-ascent (day 8)
Cardial arrhythmias during descent and re-ascent
大体时间:From day of descent (day 1) and day of re-ascent (day 8)
Occurrence/changes in cardial arrhythmias at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in healthy individuals
From day of descent (day 1) and day of re-ascent (day 8)
Pulse transit time during descent and re-ascent
大体时间:From day of descent (day 1) and day of re-ascent (day 8)
Occurrence and difference/change in pulse transit time (drops) at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in healthy individuals
From day of descent (day 1) and day of re-ascent (day 8)

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3日

研究记录更新

最后更新发布 (实际的)

2026年9月3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

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.

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