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Not yet recruitingNCT07804472Updated Sep 4, 2026

Assessment of Six-minute Walking Distance 6MWD 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 Six-minute Walk Test, 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: 2850m) to sea level on six-minute walking distance and scores in patients with pulmonary arterial hypertension PAH, who live permanently >2600m.

Read the detailed description

The aim of this research is to investigate the six-minute walking distance and scores before and after descent (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
  • Six-minute Walk Test
  • High Altitude Effects
  • High Altitude

Keywords

  • Hypoxia
  • High Altitude
  • Pulmonary Hypertension
  • 6-minute walking distance
  • Pulmonary Arterial Hypertension
  • NYHA
03

Who can participate

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

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
  • NYHA (new york heart association) functional class I-III
  • written informed consent 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 (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
  • Severely hypoxemic patients at Quito: permanently having persistent SpO2 (oxygen saturation by pulse-oximetry) \<80% on ambient air.
  • Patient with a non-corrected ventricular septum defect
  • Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)
04

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
    Six-minute walking distance 6MWD at 2850m and at sea level

    Assessment of the six-minute walking distance and scores 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 assessment of the same outcomes

    Behavioral: Descent from 2850m to sea level

Interventions

  • BehavioralDescent from 2850m to sea level

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

05

What researchers measure

Primary outcomes

  1. Six-minute walking distance (m) after 7 days at sea level

    Difference/change in six-minute walking distance 6MWD 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. SpO2 (peripheral oxygen saturation, %) at rest and end-exercise after 7 days at sea level

    Difference/change in SpO2 (peripheral oxygen saturation) at rest and end-exercise 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. Heart rate (beats per minute) at rest and end-exercise after 7 days at sea level

    Difference/change in heart rate at rest and end-exercise 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

  3. Blood pressure (mmHg) at rest and end-exercise after 7 days at sea level

    Difference/change in blood pressure at rest and end-exercise 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. Dyspnea and leg discomfort sensation after 7 days at sea level

    Difference/change in dyspnea and leg discomfort sensation (assessed with BORG-CR10-Scale, Category Rating 0-10 with 10 being the most dyspnea/leg discomfort) at rest and end-exercise between 2850m and 5-7 days at sea level in patients with pulmonary arterial hypertension

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

  5. NYHA functional class (1-4) after 7 days at sea level

    Difference/change in NYHA functional class (New York Heart Association Class I-IV, IV being the worst) at rest and end-exercise between 2850m and 5-7 days at sea level in patients with pulmonary arterial hypertension

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

  6. Quality of life after 7 days at sea level

    Difference/change in quality of life score (EmPHasis-10: Score with 10 questions and 0-50 points, higher scores indicating poorer quality of life) between 2850m and 5-7 days at sea level in patients with pulmonary arterial hypertension

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

  7. General well-being after 7 days at sea level

    Difference/change in general well-being (Visual Analog Scale 10cm: the higher, the worse) 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

  8. Acclimatization-effect of six-minute walking distance (m) at sea level

    Difference/change in six-minute walking distance (6MWD) within a stay at sea level of 7 days (after descent from 2850m) in patients with pulmonary arterial hypertension

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

  9. Acclimatization-Effect of SpO2 (%) at rest and end-exercise at sea level

    Difference/change in SpO2 (peripheral oxygen saturation) at rest and end-exercise within a stay at sea level of 7 days (after descent from 2850m) in patients with pulmonary arterial hypertension

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

  10. Acclimatization-Effect of heart rate (beats per minute) at rest and end-exercise at sea level

    Difference/change in heart rate at rest and end-exercise within a stay at sea level of 7 days (after descent from 2850m) in patients with pulmonary arterial hypertension

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

  11. Acclimatization-Effect of blood pressure (mmHg) at rest and end-exercise at sea level

    Difference/change in blood pressure at rest and end-exercise within a stay at sea level of 7 days (after descent from 2850m) in patients with pulmonary arterial hypertension

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

  12. Acclimatization-Effect of dyspnea and leg discomfort at sea level

    Difference/change in dyspnea and leg discomfort (assessed with BORG-CR10-Scale, Category Rating 0-10 with 10 being the most dyspnea/leg discomfort) at rest and end-exercise within a stay at sea level of 7 days (after descent from 2850m) in patients with pulmonary arterial hypertension

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

  13. Acclimatization-Effect of NYHA functional class (1-4) at sea level

    Difference/change in NYHA functional class (New York Heart Association Class I-IV, IV being the worst) at rest and end-exercise within a stay of 7 days at sea level (after descent from 2850m) in patients with pulmonary arterial hypertension

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

  14. Acclimatization-Effect of Quality of Life at sea level

    Difference/change in quality of life (EmPHasis-10: Score with 10 questions and 0-50 points, higher scores indicating poorer quality of life) within a stay of 7 days at sea level (after descent from 2850m) in patients with pulmonary arterial hypertension

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

  15. Acclimatization-Effect of general well-being at sea level

    Difference/change in general well-being (Visual Analog Scale 10cm: the higher, the worse) within a stay of 7 days at sea level (after descent from 2850m) in patients with pulmonary arterial hypertension

    Time frame: From Day 2 to Day 5-7 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
NCT07804472
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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