Echocardiography, Hemodynamic Changes, High Altitude, Pulmonary Arterial Hypertension (PAH), Pulmonary Resistance, Pulmonary Vascular Disease
Conditions
Keywords
Pulmonary Arterial Hypertension (PAH), Hypoxia, High Altitude, Pulmonary Hypertension, Pulmonary Resistance, Pulmonary vascular disease, Echocardiography, hemodynamics
Brief summary
To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes in patients with pulmonary arterial hypertension PAH, who live permanently \>2600m.
Detailed description
The aim of this research is to investigate the pulmonary resistance (sPAP/CO) by echocardiography and other hemodynamic outcomes before and after relocation (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 a 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 relocation 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 2850m 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 |
|---|---|---|
| Pulmonary resistance (sPAP/CO) after 7 days at sea level | From high altitude (2850m) to day 5-7 at sea level | Difference in sPAP/CO by echocardiography between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acclimatization-Effect of PaO2 at sea level | From Day 2 to Day 7 at sea level | Difference/change in PaO2 (arterial blood gas analysis) within a stay at sea level for 7 days (after relocation from high altitude) |
| Acclimatization-Effect of PaCO2 at sea level | From Day 2 to Day 7 at sea level | Difference/change in PaCO2 (arterial blood gas analysis) within a stay at sea level for 7 days (after relocation from high altitude) |
| Acclimatization-Effect of hemoglobin at sea level | From Day 2 to Day 7 at sea level | Difference/change in hemoglobin (arterial blood gas analysis) within a stay at sea level for 7 days (after relocation from high altitude) |
| Acclimatization-Effect of pH at sea level | From Day 2 to Day 7 at sea level | Difference/change in pH (arterial blood gas analysis) within a stay at sea level for 7 days (after relocation from high altitude) |
| Tricuspid regurgitation velocity TRV after 7 days at sea level | From high altitude (2850m) to day 5-7 at sea level | Difference in tricuspid regurgitation velocity TRV between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension |
| Cardiac output CO after 7 days at sea level | From high altitude (2850) to day 5-7 at sea level | Difference/change in cardiac output CO between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension |
| Tricuspid annular plan systolic excursion TAPSE after 7 days at sea level | From high altitude (2850m) to day 5-7 at sea level | Difference/change in tricuspid annular plan systolic excursion TAPSE between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension |
| Right ventricular strain after 7 days at sea level | From high altitude (2850m) to Day 5-7 at sea level | Difference/change in right ventricular strain between 2850m and day 5-7 at sea level in patients with pulmonary arterial hypertension |
| Right atrial pressure RAP after 7 days at sea level | From high altitude (2850m) to Day 5-7 at sea level | Difference/change in right atrial pressure RAP between 2850m and day 5-7 at sea level in patients with pulmonary arterial hypertension |
| Fractional area change FAC after 7 days at sea level | From high altitude (2850m) to Day 5-7 at sea level | Difference/change in fractional area change FAC between 2850m and day 5-7 at sea level in patients with pulmonary arterial hypertension |
| PaO2 after 7 days at sea level | From high altitude (2850) to day 5-7 at sea level | Difference/change in PaO2 (arterial blood gas analysis) between 2850m and sea level in patients with pulmonary arterial hypertension |
| PaCO2 after 7 days at sea level | From high altitude (2850) to day 5-7 at sea level | Difference/change in PaCO2 (arterial blood gas analysis) between 2850m and sea level in patients with pulmonary arterial hypertension |
| Hemoglobin after 7 days at sea level | From high altitude (2850) to day 5-7 at sea level | Difference/change in hemoglobin (arterial blood gas analysis) between 2850m and sea level in patients with pulmonary arterial hypertension |
| pH after 7 days at sea level | From high altitude (2850) to day 5-7 at sea level | Difference/change in pH(arterial blood gas analysis) between 2850m and sea level in patients with pulmonary arterial hypertension |
| Acclimatization-Effect of pulmonary resistance (sPAP/CO) at sea level | From Day 2 to Day 5-7 at sea level | Difference/change in pulmonary resistance (sPAP/CO) within a stay at sea level of 7 days (after relocation from high altitude) |
| Acclimatization-Effect of tricuspid regurgitation velocity TRV at sea level | From Day 2 to Day 5-7 at sea level | Difference/change in tricuspid regurgitation velocity TRV within a stay at sea level of 7 days (after relocation from high altitude) |
| Acclimatization-Effect of cardiac output CO at sea level | From Day 2 to Day 5-7 at sea level | Difference/change in cardiac output CO within a stay at sea level of 7 days (after relocation from high altitude) |
| Acclimatization-Effect of tricuspid annular plan systolic excursion TAPSE at sea level | From Day 2 to day 5-7 at sea level | Difference/change in tricuspid annular plan systolic excursion TAPSE within a stay at sea level for 7 days (after relocation from high altitude) |
| Acclimatization-Effect of right ventricular strain at sea level | From Day 2 to Day 5-7 at sea level | Difference/change in right ventricular strain within a stay at sea level for 7 days (after relocation from high altitude) |
| Acclimatization-Effect of fractional area change FAC at sea level | From Day 2 to Day 5-7 at sea level | Difference/change in fractional area change FAC within a stay at sea level for 7 days (after relocation from high altitude) |
| Acclimatization-Effect of right atrial pressure RAP at sea level | From Day 2 to Day 5-7 at sea level | Difference/change in right atrial pressure RAP within a stay at sea level for 7 days (after relocation from high altitude) |
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