An interventional study of Re-Ascent sea level to 2850m 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 2026-09-01.
Sponsored by Silvia Ulrich Somaini · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
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)
Behavioral: Re-Ascent sea level to 2850m
After 7 days at sea level return/re-ascent to their usual living altitude at 2850m
Six-minute walking distance after re-ascent to 2850m
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
Time frame: From Day 5-7 at sea level to day after re-ascent
SpO2 at rest and end-exercise after re-ascent to 2850m
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
Time frame: From Day 5-7 at sea level to day after re-ascent
Heart rate at rest and end-exercise after re-ascent to 2850m
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
Time frame: From Day 5-7 at sea level to day after re-ascent
Blood pressure at rest and end-exercise after re-ascent to 2850m
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
Time frame: From Day 5-7 at sea level to day after re-ascent
Dyspnea and leg discomfort sensation after re-ascent to 2850m
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
Time frame: From Day 5-7 at sea level to day after re-ascent
NYHA functional class after re-ascent to 2850m
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
Time frame: From Day 5-7 at sea level to day after re-ascent
Quality of life after re-ascent to 2850m
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
Time frame: From Day 5-7 at sea level to day after re-ascent
General well-being after re-ascent to 2850m
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
Time frame: From Day 5-7 at sea level to day after re-ascent
Six-minute walking distance pre-descent to after re-ascent
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
Time frame: 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)
SpO2 at rest and end-exercise pre-descent to after re-ascent
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
Time frame: 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)
Heart rate at rest and end-exercise pre-descent to after re-ascent
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
Time frame: 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)
Blood pressure at rest and end-exercise pre-descent to after re-ascent
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
Time frame: 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)
Dyspnea and leg discomfort pre-descent to after re-ascent
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
Time frame: 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)
NYHA functional class pre-descent to after re-ascent
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
Time frame: 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)
Quality of life pre-descent to after re-ascent
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
Time frame: 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)
General well-being pre-descent to after re-ascent
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
Time frame: 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)
Plan to share: Yes — Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
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Pulmonary Arterial Hypertension→
Silvia Ulrich Somaini