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
| Registry | NCT07797166 |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, supportive care |
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| Enrollment | 20 (Estimated) |
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| Sponsor | Silvia Ulrich Somaini (Other) |
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| Conditions | Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease, Six-minute Walk Test, NYHA, High Altitude Effects, High Altitude |
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| Interventions | Re-Ascent sea level to 2850m (Behavioral) |
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| Dates | start 2026-09-25 (estimated), primary completion 2026-10-04 (estimated), completion 2026-12-31 (estimated), first posted 2026-09-01, last updated 2026-09-01 |
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| Locations | 1 site in Switzerland |
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All trials for Pulmonary Arterial Hypertension (PAH) All trials for Pulmonary Vascular Disease All trials of Re-Ascent sea level to 2850m
-Summary
To study the effect of a re-ascent after a one-week stay at sea level (after prior descent from 2850m) to high altitude (Quito Ecuador: 2850m) on six-minute walking distance and other scores in patients with pulmonary arterial hypertension PAH, who live permanently >2600m.
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+Detailed description
The aim of this research is to investigate the six-minute walking distance and other scores before and after re-ascent (sea level for 7 days vs. re-ascent to 2850m) in patients with diagnosed pulmonary arterial hypertension according to guidelines, who permanently live at high altitude over 2600m.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Six-minute walking distance 6MWD at sea level and after re-ascent at 2850m | Experimental | Behavioral: Re-Ascent sea level to 2850m | Assessment of six-minute walking distance 6MWD and other scores after 7 days at sea level and after re-ascent from sea level back to 2850m by bus (in one day) |
- Re-Ascent sea level to 2850m (Behavioral): After 7 days at sea level return/re-ascent to their usual living altitude at 2850m
+Outcome measures
Primary outcomes
- Six-minute walking distance after re-ascent to 2850m [From Day 5-7 at sea level to day after re-ascent]: Difference/change in six-minute walking distance 6MWD between sea level (after one-week stay) and day after re-ascent at 2850m in patients with pulmonary arterial hypertension
Secondary outcomes
- SpO2 at rest and end-exercise after re-ascent to 2850m [From Day 5-7 at sea level to day after re-ascent]: Difference/change in SpO2 (peripheral oxygen saturation) at rest and end-exercise between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension
- Heart rate at rest and end-exercise after re-ascent to 2850m [From Day 5-7 at sea level to day after re-ascent]: Difference/change in heart rate at rest and end-exercise between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension
- Blood pressure at rest and end-exercise after re-ascent to 2850m [From Day 5-7 at sea level to day after re-ascent]: Difference/change in blood pressure at rest and end-exercise between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension
- Dyspnea and leg discomfort sensation after re-ascent to 2850m [From Day 5-7 at sea level to day after re-ascent]: 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 sea level (after one-week stay) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
- NYHA functional class after re-ascent to 2850m [From Day 5-7 at sea level to day after re-ascent]: Difference/change in NYHA functional class (New York Heart Association Class I-IV, IV being the worst) at rest and end-exercise between sea level (after one-week stay) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
- Quality of life after re-ascent to 2850m [From Day 5-7 at sea level to day after re-ascent]: 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 sea level (after one-week stay) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
- General well-being after re-ascent to 2850m [From Day 5-7 at sea level to day after re-ascent]: Difference/change in general well-being (Visual Analog Scale 10cm: the higher, the worse) between sea level (after one-week stay) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
- Six-minute walking distance pre-descent to after re-ascent [Baseline at 2850m followed by a one-week stay at sea level to day after re-ascent back to 2850m (time frame approximately 11 days)]: Difference/change in six-minute walking distance (6MWD) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
- SpO2 at rest and end-exercise pre-descent to after re-ascent [Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)]: Difference/change in SpO2 (peripheral oxygen saturation) at rest and end-exercise at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
- Heart rate at rest and end-exercise pre-descent to after re-ascent [Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)]: Difference/change in heart rate at rest and end-exercise at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
- Blood pressure at rest and end-exercise pre-descent to after re-ascent [Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)]: Difference/change in blood pressure at rest and end-exercise at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
- Dyspnea and leg discomfort pre-descent to after re-ascent [Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)]: 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 at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
- NYHA functional class pre-descent to after re-ascent [Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)]: Difference/change in NYHA functional class (New York Heart Association Class I-IV, IV being the worst) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
- Quality of life pre-descent to after re-ascent [Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)]: Difference/change in quality of life (EmPHasis-10: Score with 10 questions and 0-50 points, higher scores indicating poorer quality of life) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
- General well-being pre-descent to after re-ascent [Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)]: Difference/change in general well-being (Visual Analog Scale 10cm: the higher, the worse) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
+Eligibility
Sex: All, ages: 18 Years to 80 Years
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:
* 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 pulseoximetry) <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)
+Locations (1)
| Facility | City | Country | Status |
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| University Hospital of Zurich | Zurich | Switzerland | |
+Investigators
- Silvia Ulrich, Principal investigator, University Hospital Zurich, Departement of Pulmonology
- Rodrigo Hoyos, Principal investigator, Hospital Carlos Andrade Marin of Quito, Ecuador