High AltitudeNCT07804485
Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
A study testing Descent from 2850m to sea level in people with High Altitude and Healthy Adult, run by Silvia Ulrich Somaini at 1 site in Switzerland.
Trial summary
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 healthy individuals, who live permanently >2600m. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- High Altitude, Healthy Adult, Echocardiography
- What is being tested?
- Descent from 2850m to sea level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age <18 years or >80 years
- People who cannot follow the study investigations
- Participant permanently living < 2600m.
- Participant who traveled and stayed overnight at altitudes <2000 m in the past 4 weeks.
- any self-perceived cardiopulmonary disease limiting daily activities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Furian, Prof. Dr. sc. ETH contact
About this study
Official title: 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 on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes in healthy individuals, who live permanently >2600m.
Read the detailed description
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 healthy individuals, who permanently live at high altitude over 2600m.
- Conditions
- High Altitude, Healthy Adult, Echocardiography, Pulmonary Resistance, Hemodynamic Changes, Healthy
- Being tested
- Descent from 2850m to sea level
- Keywords
- Hypoxia, High altitude, Health, Echocardiography, Pulmonary resistance, Hemodynamics
- Medical subject headings
- Altitude Sickness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descent from 2850m to sea levelBehavioural
Descent from 2850m to sea level with a stay for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Descent from 2850m to sea level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary resistance (sPAP/CO) after 7 days at sea level
Difference/change in sPAP/CO by echocardiography between 2850m and Day 5-7 at sea level in healthy individuals
Measured: From high altitude (2850m) to day 5-7 at sea level
Secondary outcomes (21)
Tricuspid regurgitation velocity TRV after 7 days at sea level
Difference/change in tricuspid regurgitation velocity TRV between 2850m and Day 5-7 at sea level in healthy individuals
Measured: From high altitude (2850m) to day 5-7 at sea level
Cardiac output CO after 7 days at sea level
Difference/change in cardiac output CO between 2850m and Day 5-7 at sea level in healthy individuals
Measured: From high altitude (2850) to day 5-7 at sea level
Tricuspid annular plan systolic excursion TAPSE after 7 days at sea level
Difference/change in tricuspid annular plan systolic excursion TAPSE between 2850m and Day 5-7 at sea level in healthy individuals
Measured: From high altitude (2850m) to day 5-7 at sea level
Right ventricular strain after 7 days at sea level
Difference/change in right ventricular strain between 2850m and day 5-7 at sea level in healthy individuals
Measured: From high altitude (2850m) to Day 5-7 at sea level
Right atrial pressure RAP after 7 days at sea level
Difference/change in right atrial pressure RAP between 2850m and day 5-7 at sea level in healthy individuals
Measured: From high altitude (2850m) to Day 5-7 at sea level
Fractional area change FAC after 7 days at sea level
Difference/change in fractional area change FAC between 2850m and day 5-7 at sea level in healthy individuals
Measured: From high altitude (2850m) to Day 5-7 at sea level
PaO2 after 7 days at sea level
Difference/change in PaO2 (arterial blood gas analysis) between 2850m and sea level in healthy individuals
Measured: From high altitude (2850) to day 7 at sea level
PaCO2 after 7 days at sea level
Difference/change in PaCO2 (arterial blood gas analysis) between 2850m and sea level in healthy individuals
Measured: From high altitude (2850) to day 7 at sea level
Hemoglobin after 7 days at sea level
Difference/change in hemoglobin (arterial blood gas analysis) between 2850m and sea level in healthy individuals
Measured: From high altitude (2850) to day 7 at sea level
pH after 7 days at sea level
Difference/change in pH (arterial blood gas analysis) between 2850m and sea level in healthy individuals
Measured: From high altitude (2850) to day 7 at sea level
Acclimatization-Effect of pulmonary resistance (sPAP/CO) at sea level
Difference/change in pulmonary resistance (sPAP/CO) within a stay at sea level of 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of tricuspid regurgitation velocity TRV at sea level
Difference/change in tricuspid regurgitation velocity TRV within a stay at sea level of 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of cardiac output CO at sea level
Difference/change in cardiac output CO within a stay at sea level of 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of tricuspid annular plan systolic excursion TAPSE at sea level
Difference/change in tricuspid annular plan systolic excursion TAPSE within a stay at sea level for 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of right ventricular strain at sea level
Difference/change in right ventricular strain within a stay at sea level for 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of right atrial pressure RAP at sea level
Difference/change in right atrial pressure RAP within a stay at sea level for 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of fractional area change FAC at sea level
Difference/change in fractional area change FAC within a stay at sea level for 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of PaO2 at sea level
Difference/change in PaO2 (arterial blood gas analysis) within a stay at sea level for 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 7 at sea level
Acclimatization-Effect of PaCO2 at sea level
Difference/change in PaCO2 (arterial blood gas analysis) within a stay at sea level for 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 7 at sea level
Acclimatization-Effect of hemoglobin at sea level
Difference/change in hemoglobin (arterial blood gas analysis) within a stay at sea level for 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 7 at sea level
Acclimatization-Effect of pH at sea level
Difference/change in pH (arterial blood gas analysis) within a stay at sea level for 7 days (after relocation from high altitude) in healthy individuals
Measured: From Day 2 to Day 7 at sea level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start25 Sep 2026 (estimated)
- Primary completion4 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High AltitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Healthy individuals living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m and after relocation to sea level
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silvia Ulrich Somaini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Silvia Ulrich Somaini, University of Zurich
- Investigators
- Silvia Ulrich, Principal investigator, University Hospital Zurich, Departement of PulmonologyRodrigo Hoyos, Principal investigator, Hospital Carlos Andrade Marin of Quito, Ecuador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804485
- Sponsor's protocol ID
- Ec_HAvsLA_sPAP/CO_H
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07804485
- Acronym / sponsor ID
- Ec_HAvsLA_sPAP/CO_H
- Conditions
- High Altitude, Healthy Adult, Echocardiography, Pulmonary Resistance, Hemodynamic Changes, Healthy
- Keywords
- Hypoxia, High altitude, Health, Echocardiography, Pulmonary resistance, Hemodynamics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Silvia Ulrich SomainiUniversity, hospital or other
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 4 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 healthy individuals, who live permanently >2600m.
Detailed description
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 healthy individuals, who permanently live at high altitude over 2600m.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy individuals living permanently > 2600m around Quito (Ecuador) will be assessed at 2850m and after relocation to sea level
| Arm | Type | Receives |
|---|---|---|
| Pulmonary resistance (sPAP/CO) at 2850m and at sea level | Experimental | Behavioral: Descent from 2850m to sea levelMeasurement 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Age <18 years or >80 years
- People who cannot follow the study investigations
- Participant permanently living < 2600m.
- Participant who traveled and stayed overnight at altitudes <2000 m in the past 4 weeks.
- any self-perceived cardiopulmonary disease limiting daily activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Descent from 2850m to sea levelDescent from 2850m to sea level with a stay for 7 days | Behavioural | Pulmonary resistance (sPAP/CO) at 2850m and at sea level |
Primary outcome
Pulmonary resistance (sPAP/CO) after 7 days at sea level
Time frame: From high altitude (2850m) to day 5-7 at sea level
Difference/change in sPAP/CO by echocardiography between 2850m and Day 5-7 at sea level in healthy individuals
21 secondary outcomes
Tricuspid regurgitation velocity TRV after 7 days at sea level
Time frame: From high altitude (2850m) to day 5-7 at sea level
Cardiac output CO after 7 days at sea level
Time frame: From high altitude (2850) to day 5-7 at sea level
Tricuspid annular plan systolic excursion TAPSE after 7 days at sea level
Time frame: From high altitude (2850m) to day 5-7 at sea level
Right ventricular strain after 7 days at sea level
Time frame: From high altitude (2850m) to Day 5-7 at sea level
Right atrial pressure RAP after 7 days at sea level
Time frame: From high altitude (2850m) to Day 5-7 at sea level
Fractional area change FAC after 7 days at sea level
Time frame: From high altitude (2850m) to Day 5-7 at sea level
PaO2 after 7 days at sea level
Time frame: From high altitude (2850) to day 7 at sea level
PaCO2 after 7 days at sea level
Time frame: From high altitude (2850) to day 7 at sea level
Hemoglobin after 7 days at sea level
Time frame: From high altitude (2850) to day 7 at sea level
pH after 7 days at sea level
Time frame: From high altitude (2850) to day 7 at sea level
Acclimatization-Effect of pulmonary resistance (sPAP/CO) at sea level
Time frame: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of tricuspid regurgitation velocity TRV at sea level
Time frame: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of cardiac output CO at sea level
Time frame: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of tricuspid annular plan systolic excursion TAPSE at sea level
Time frame: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of right ventricular strain at sea level
Time frame: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of right atrial pressure RAP at sea level
Time frame: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of fractional area change FAC at sea level
Time frame: From Day 2 to Day 5-7 at sea level
Acclimatization-Effect of PaO2 at sea level
Time frame: From Day 2 to Day 7 at sea level
Acclimatization-Effect of PaCO2 at sea level
Time frame: From Day 2 to Day 7 at sea level
Acclimatization-Effect of hemoglobin at sea level
Time frame: From Day 2 to Day 7 at sea level
Acclimatization-Effect of pH at sea level
Time frame: From Day 2 to Day 7 at sea level
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Furian, Prof. Dr. sc. ETH contact
Silvia Ulrich principal investigator
University Hospital Zurich, Departement of Pulmonology
Rodrigo Hoyos principal investigator
Hospital Carlos Andrade Marin of Quito, Ecuador
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Descent from 2850m to sea level in people with High Altitude and Healthy Adult, run by Silvia Ulrich Somaini at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Ulrich, Prof. Dr. med. (+41442552220, silvia.ulrich@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary resistance (sPAP/CO) after 7 days at sea level (time frame: From high altitude (2850m) to day 5-7 at sea level). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.