High Altitude, High Altitude Effects, Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease, Six-minute Walk Test
Conditions
Keywords
Hypoxia, High Altitude, Pulmonary Hypertension, 6-minute walking distance, Pulmonary Arterial Hypertension, NYHA
Brief 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.
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.
Interventions
BEHAVIORALDescent from 2850m to sea level
Descent from 2850m to sea level with stay for 7 days
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 at 2850m and after descent to sea level
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 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute walking distance (m) after 7 days at sea level | From high altitude (2850m) to day 5-7 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acclimatization-Effect of Quality of Life at sea level | From Day 2 to Day 5-7 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 |
| Acclimatization-Effect of general well-being at sea level | From Day 2 to Day 5-7 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 |
| Acclimatization-Effect of dyspnea and leg discomfort at sea level | From Day 2 to Day 5-7 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 |
| SpO2 (peripheral oxygen saturation, %) at rest and end-exercise after 7 days at sea level | From high altitude (2850m) to day 5-7 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 |
| Heart rate (beats per minute) at rest and end-exercise after 7 days at sea level | From high altitude (2850m) to day 5-7 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 |
| Blood pressure (mmHg) at rest and end-exercise after 7 days at sea level | From high altitude (2850m) to day 5-7 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 |
| Dyspnea and leg discomfort sensation after 7 days at sea level | From high altitude (2850m) to day 5-7 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 |
| NYHA functional class (1-4) after 7 days at sea level | From high altitude (2850m) to day 5-7 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 |
| Quality of life after 7 days at sea level | From high altitude (2850m) to day 5-7 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 |
| General well-being after 7 days at sea level | From high altitude (2850m) to Day 5-7 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 |
| Acclimatization-effect of six-minute walking distance (m) at sea level | From Day 2 to Day 5-7 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 |
| Acclimatization-Effect of SpO2 (%) at rest and end-exercise at sea level | From Day 2 to Day 5-7 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 |
| Acclimatization-Effect of heart rate (beats per minute) at rest and end-exercise at sea level | From Day 2 to Day 5-7 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 |
| Acclimatization-Effect of NYHA functional class (1-4) at sea level | From Day 2 to Day 5-7 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 |
| Acclimatization-Effect of blood pressure (mmHg) at rest and end-exercise at sea level | From Day 2 to Day 5-7 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 |
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