Pulmonary Arterial Hypertension (PAH)NCT07804472
Assessment of Six-minute Walking Distance 6MWD Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
A study testing Descent from 2850m to sea level in people with Pulmonary Arterial Hypertension (PAH) and Pulmonary Vascular Disease, run by Silvia Ulrich Somaini at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease, Six-minute Walk Test
- 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
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Sep 2026to 31 Dec 2026
- Phase
- Interventional
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
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: 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.
- Conditions
- Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease, Six-minute Walk Test, High Altitude Effects, High Altitude
- Being tested
- Descent from 2850m to sea level
- Keywords
- Hypoxia, High Altitude, Pulmonary Hypertension, 6-minute walking distance, Pulmonary Arterial Hypertension, NYHA
- Medical subject headings
- Pulmonary Arterial Hypertension, Altitude Sickness, Hypoxia, Hypertension, Pulmonary
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 stay for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Six-minute walking distance 6MWD at 2850m and at sea level | Experimental | 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 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.
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
Measured: From high altitude (2850m) to day 5-7 at sea level
Secondary outcomes (15)
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
Measured: From high altitude (2850m) to day 5-7 at sea level
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
Measured: From high altitude (2850m) to day 5-7 at sea level
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
Measured: From high altitude (2850m) to day 5-7 at sea level
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
Measured: From high altitude (2850m) to day 5-7 at sea level
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
Measured: From high altitude (2850m) to day 5-7 at sea level
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
Measured: From high altitude (2850m) to day 5-7 at sea level
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
Measured: From high altitude (2850m) to Day 5-7 at sea level
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
Measured: From Day 2 to Day 5-7 at sea level
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
Measured: From Day 2 to Day 5-7 at sea level
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
Measured: From Day 2 to Day 5-7 at sea level
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
Measured: From Day 2 to Day 5-7 at sea level
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
Measured: From Day 2 to Day 5-7 at sea level
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
Measured: From Day 2 to Day 5-7 at sea level
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
Measured: From Day 2 to Day 5-7 at sea level
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
Measured: From Day 2 to Day 5-7 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 Pulmonary Arterial Hypertension (PAH)Studies 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
- Patients diagnosed with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m and after descent to sea level
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07804472
- Sponsor's protocol ID
- Ec_HAvsLA_6MWD_PAH
- 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.