High Altitude, High Altitude Effects, Lung Function Changes, Lung Function Testing, Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Conditions
Keywords
Pulmonary arterial hypertension PAH, Pulmonary vascular disease, High Altitude, Lung function, forced oscillation technique
Brief summary
To study the effect of a re-ascent to high altitude (Quito Ecuador: 2850m) after a one-week stay at sea level (after prior descent from 2850m) on lung function and pulmonary resistance/reactance in patients with pulmonary arterial disease PAH, who live permanently \> 2600m.
Detailed description
The aim of this research is to investigate the lung function and pulmonary resistance/reactance before and after re-ascent (sea level for 7 days after prior descent from 2850m vs. re-ascent to 2850m) in patients with diagnosed pulmonary hypertension according to guidelines, who permanently live at high altitude over 2600m.
Interventions
BEHAVIORALRe-ascent from sea level to 2850m
Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back 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 with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m, after relocation to sea level for 7 days and after re-ascent
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 |
|---|---|---|
| FEV1 after re-ascent to 2850m | From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days) | Difference/change in forced expiratory volume in one second FEV1 between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Vital Capacity FVC after re-ascent to 2850m | From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days) | Difference/change in forced vital capacity FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| FEV1/FVC after re-ascent to 2850m | From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days) | Difference/change in FEV1/FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Respiratory Impedance (forced oscillation technique) after re-ascent to 2850m | From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days) | Difference/change in respiratory impedance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Respiratory resistance (forced oscillation technique) after re-ascent to 2850m | From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days) | Difference/change in respiratory resistance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Respiratory reactance (forced oscillation technique) after re-ascent to 2850m | From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days) | Difference/change in respiratory reactance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| FEV1 after 4 days at sea level | From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days) | Difference/change in FEV1 between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease |
| Forced Vital Capacity FVC after 4 days at sea level | From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days) | Difference/change in forced vital capacity FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease |
| FEV1/FVC after 4 days at sea level | From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days) | Difference/change in FEV1/FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease |
| Respiratory Impedance (forced oscillation technique) after 4 days at sea level | From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days) | Difference/change in respiratory impedance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease |
| Respiratory resistance (forced oscillation technique) after 4 days at sea level | From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days) | Difference/change in respiratory resistance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease |
| Respiratory reactance (forced oscillation technique) after 4 days at sea level | From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days) | Difference/change in respiratory reactance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease |
| FEV1 pre-descent and after re-ascent (2850m) | 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 FEV1 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 disease |
| Forced Vital Capacity FVC pre-descent and after re-ascent (2850m) | 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 forced vital capacity FVC 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 |
| FEV1/FVC pre-descent and after re-ascent (2850m) | 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 FEV1/FVC 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 |
| Respiratory Impedance (forced oscillation technique) pre-descent and after re-ascent (2850m) | 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 respiratory impedance (forced oscillation technique) 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 |
| Respiratory resistance (forced oscillation technique) pre-descent and after re-ascent (2850m) | 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 respiratory resistance (forced oscillation technique) 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 |
| Respiratory reactance (forced oscillation technique) pre-descent and after re-ascent (2850m) | 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 respiratory reactance (forced oscillation technique) 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