- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07801846
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
August 31, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Interventional
Enrollment (Estimated)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Silvia Ulrich, Prof. Dr. med.
- Phone Number: +41442552220
- Email: silvia.ulrich@usz.ch
Study Contact Backup
- Name: Michael Furian, Prof. Dr. sc. ETH
- Phone Number: +41442552220
Study Locations
-
-
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Zurich, Switzerland, 8091
- University Hospital of Zurich
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate variability HRV during descent and re-ascent
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SpO2 during descent and re-ascent
Time Frame: 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
Time Frame: 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
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From day of descent (day 1) and day of re-ascent (day 8)
|
|
Cardial arrhythmias during descent and re-ascent
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Principal Investigator: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 25, 2026
Primary Completion (Estimated)
October 4, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
August 17, 2026
First Submitted That Met QC Criteria
August 31, 2026
First Posted (Actual)
September 3, 2026
Study Record Updates
Last Update Posted (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
August 31, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ec_DEvsA_HRV_H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.