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Not yet recruitingNCT07804485Updated Sep 4, 2026

Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H

An interventional study of Descent from 2850m to sea level in High Altitude, Healthy Adult and Echocardiography, sponsored by Silvia Ulrich Somaini. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Silvia Ulrich Somaini · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • High Altitude
  • Healthy Adult
  • Echocardiography
  • Pulmonary Resistance
  • Hemodynamic Changes
  • Healthy

Keywords

  • Hypoxia
  • High altitude
  • Health
  • Echocardiography
  • Pulmonary resistance
  • Hemodynamics
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    Pulmonary resistance (sPAP/CO) at 2850m and at sea level

    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

    Behavioral: Descent from 2850m to sea level

Interventions

  • BehavioralDescent from 2850m to sea level

    Descent from 2850m to sea level with a stay for 7 days

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: From high altitude (2850m) to day 5-7 at sea level

Secondary outcomes

  1. 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

    Time frame: From high altitude (2850m) to day 5-7 at sea level

  2. 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

    Time frame: From high altitude (2850) to day 5-7 at sea level

  3. 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

    Time frame: From high altitude (2850m) to day 5-7 at sea level

  4. 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

    Time frame: From high altitude (2850m) to Day 5-7 at sea level

  5. 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

    Time frame: From high altitude (2850m) to Day 5-7 at sea level

  6. 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

    Time frame: From high altitude (2850m) to Day 5-7 at sea level

  7. PaO2 after 7 days at sea level

    Difference/change in PaO2 (arterial blood gas analysis) between 2850m and sea level in healthy individuals

    Time frame: From high altitude (2850) to day 7 at sea level

  8. PaCO2 after 7 days at sea level

    Difference/change in PaCO2 (arterial blood gas analysis) between 2850m and sea level in healthy individuals

    Time frame: From high altitude (2850) to day 7 at sea level

  9. Hemoglobin after 7 days at sea level

    Difference/change in hemoglobin (arterial blood gas analysis) between 2850m and sea level in healthy individuals

    Time frame: From high altitude (2850) to day 7 at sea level

  10. pH after 7 days at sea level

    Difference/change in pH (arterial blood gas analysis) between 2850m and sea level in healthy individuals

    Time frame: From high altitude (2850) to day 7 at sea level

  11. 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

    Time frame: From Day 2 to Day 5-7 at sea level

  12. 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

    Time frame: From Day 2 to Day 5-7 at sea level

  13. 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

    Time frame: From Day 2 to Day 5-7 at sea level

  14. 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

    Time frame: From Day 2 to Day 5-7 at sea level

  15. 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

    Time frame: From Day 2 to Day 5-7 at sea level

  16. 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

    Time frame: From Day 2 to Day 5-7 at sea level

  17. 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

    Time frame: From Day 2 to Day 5-7 at sea level

  18. 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

    Time frame: From Day 2 to Day 7 at sea level

  19. 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

    Time frame: From Day 2 to Day 7 at sea level

  20. 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

    Time frame: From Day 2 to Day 7 at sea level

  21. 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

    Time frame: From Day 2 to Day 7 at sea level

06

Study locations

1 site
  • University Hospital of Zurich
    Zurich, 8091, Switzerland
07

References and documents

Individual participant data

Plan to share: Yes — Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07804485
Lead sponsor
Silvia Ulrich Somaini
Responsible party
Silvia Ulrich Somaini (Prof. Dr. med., University of Zurich) — Sponsor-investigator
First posted
Sep 4, 2026
Start date
Sep 25, 2026 (estimated)
Primary completion
Oct 4, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 4, 2026

Study contacts

Silvia Ulrich, Prof. Dr. med.
Contact
silvia.ulrich@usz.ch
+41442552220
Michael Furian, Prof. Dr. sc. ETH
Contact
+41442552220
Silvia Ulrich
principal investigator · University Hospital Zurich, Departement of Pulmonology
Rodrigo Hoyos
principal investigator · Hospital Carlos Andrade Marin of Quito, Ecuador

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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