High Altitude, High Altitude Effects, NYHA, Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease, Six-minute Walk Test
Conditions
Keywords
Hypoxia, High Altitude, six-minute walking distance, Pulmonary Arterial Hypertension, NYHA, Exercise testing
Brief 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.
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.
Interventions
BEHAVIORALRe-Ascent sea level to 2850m
After 7 days at sea level return/re-ascent to their usual living altitude at 2850m
Sponsors
Silvia Ulrich Somaini
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients diagnosed with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed after 7 days at sea level and after re-ascent to 2850m
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Switzerland
Contacts
CONTACTSilvia Ulrich, Prof. Dr. med.
CONTACTMichael Furian, Prof. Dr. sc. ETH
PRINCIPAL_INVESTIGATORSilvia Ulrich
University Hospital Zurich, Departement of Pulmonology
PRINCIPAL_INVESTIGATORRodrigo Hoyos
Hospital Carlos Andrade Marin of Quito, Ecuador
Outcome results
None listed