Echocardiography, High Altitude, Pulmonary Arterial Hypertension (PAH), Pulmonary Resistance, Pulmonary Vascular Disease
Conditions
Keywords
Pulmonary Arterial Hypertension (PAH), Hypoxia, High Altitude, Pulmonary Hypertension, Pulmonary Resistance, Echocardiography, hemodynamics
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 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 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 from 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 |
|---|---|---|
| Pulmonary resistance (sPAP/CO) after re-ascent to 2850m | From Day 5-7 at sea level to day after re-ascent | Difference in sPAP/CO by echocardiography 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 |
|---|---|---|
| PaCO2 after re-ascent to 2850m | From Day 7 at sea level to day after re-ascent (time frame of 3 days) | Difference/change in PaCO2 (arterial blood gas analysis) between sea level (after one-week stay) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Hemoglobin after re-ascent to 2850m | From Day 7 at sea level to day after re-ascent (time frame of 3 days) | Difference/change in hemoglobin (arterial blood gas analysis) between sea level (after one-week stay) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| pH after re-ascent to 2850m | From Day 7 at sea level to day after re-ascent (time frame of 3 days) | Difference/change in pH (arterial blood gas analysis) between sea level (after one-week stay) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Tricuspid regurgitation velocity TRV after re-ascent to 2850m | From Day 5-7 at sea level to day after re-ascent | Difference/change in tricuspid regurgitation velocity TRV between sea level (after one-week stay) and day after re-ascent at 2850m in patients with pulmonary arterial hypertension |
| Cardiac output CO after re-ascent to 2850m | From Day 5-7 at sea level to the day after re-ascent | Difference/change in cardiac output CO between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Tricuspid annular plan systolic excursion TAPSE after re-ascent to 2850m | From Day 5-7 at sea level to day after re-ascent | Difference/change in tricuspid annular plan systolic excursion TAPSE between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Right ventricular strain after re-ascent to 2850m | From Day 5-7 at sea level to day after re-ascent | Difference/change in right ventricular strain between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Right atrial pressure RAP after re-ascent to 2850m | From Day 5-7 at sea level to day after re-ascent | Difference/change in right atrial pressure RAP between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Fractional area change FAC after re-ascent to 2850m | From Day 5-7 at sea level to day after re-ascent | Difference/change in fractional area change FAC between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| PaO2 after re-ascent to 2850m | From Day 7 at sea level to day after re-ascent (time frame of 3 days) | Difference/change in PaO2 (arterial blood gas analysis) between sea level (after one-week stay) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Tricuspid regurgitation velocity TRV 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 tricuspid regurgitation velocity TRV 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 |
| Cardiac output CO 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 cardiac output CO 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 |
| Tricuspid annular plan systolic excursion TAPSE 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 tricuspid annular plan systolic excursion TAPSE 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 |
| Right ventricular strain 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 right ventricular strain 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 |
| Right atrial pressure RAP 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 right atrial pressure RAP 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 |
| Fractional area change FAC 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 fractional area change FAC 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 |
| PaO2 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 PaO2 (arterial blood gas analysis) 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 |
| PaCO2 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 PaCO2 (arterial blood gas analysis) 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 |
| Hemoglobin 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 hemoglobin (arterial blood gas analysis) 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 |
| Pulmonary resistance (sPAP/CO) 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 pulmonary resistance (sPAP/CO) 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 |
| pH 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 pH (arterial blood gas analysis) 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