ClinicalTrials.gg
Not yet recruitingNCT07804524Updated Sep 4, 2026

Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH

An interventional study of Descent from 2850m to sea level in Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease and High Altitude, sponsored by Silvia Ulrich Somaini. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. 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
20
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 patients with pulmonary arterial hypertension PAH, 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 patients with diagnosed pulmonary arterial hypertension according to guidelines, who permanently live at high altitude over 2600m.

02

Conditions studied

  • Pulmonary Arterial Hypertension (PAH)
  • Pulmonary Vascular Disease
  • High Altitude
  • Echocardiography
  • Pulmonary Resistance
  • Hemodynamic Changes

Keywords

  • Pulmonary Arterial Hypertension (PAH)
  • Hypoxia
  • High Altitude
  • Pulmonary Hypertension
  • Pulmonary Resistance
  • Pulmonary vascular disease
  • Echocardiography
  • hemodynamics
03

In context

Pulmonary Arterial Hypertension

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Silvia Ulrich Somaini is the lead sponsor of 17 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • (new york heart association) functional class I-III
  • written to participate in the study

Exclusion criteria

Exclusion Criteria:

  • 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 (\<70% or forced vital capacity \<70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
  • Severely hypoxemic patients at 2850m 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 \<11 g/dl)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 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

06

What researchers measure

Primary outcomes

  1. Pulmonary resistance (sPAP/CO) after 7 days at sea level

    Difference in sPAP/CO by echocardiography between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension

    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 in tricuspid regurgitation velocity TRV between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension

    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 patients with pulmonary arterial hypertension

    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 patients with pulmonary arterial hypertension

    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 patients with pulmonary arterial hypertension

    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 patients with pulmonary arterial hypertension

    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 patients with pulmonary arterial hypertension

    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 patients with pulmonary arterial hypertension

    Time frame: From high altitude (2850) to day 5-7 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 patients with pulmonary arterial hypertension

    Time frame: From high altitude (2850) to day 5-7 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 patients with pulmonary arterial hypertension

    Time frame: From high altitude (2850) to day 5-7 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 patients with pulmonary arterial hypertension

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

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

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

07

Study locations

1 site
08

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Oct 2026, 0 months later.

Of 60 non-industry interventional studies with no phase under Pulmonary Arterial Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's planned 0 months is below that.

Counting every sponsor, half of 65 studies reached it within 42 months; a quarter within 18 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Sep 4, 2026
StartEst.
Sep 25, 2026
Primary completionEst.
Oct 4, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07804524
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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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