Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension, Pulmonary Vascular Disease
Conditions
Keywords
pulmonary hypertension, Pulmonary Vascular Disease, Chronic Thromboembolic Pulmonary Hypertension, high altitude, hypoxia, pulmonary artery pressure, arterial blood gases
Brief summary
To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live \>2500m on pulmonary artery pressure (PAP) and other hemodynamics.
Detailed description
This research in patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA \>2500 (PVD\_HA) will have PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m and at sea level in Pedernales the day after the first and the second night after relocation.
Interventions
BEHAVIORALRelocation from HA to LA
Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes
Sponsors
University of Zurich
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients will be investigated at high altitude (HA, 2840m) and low altitude (LA, sea level)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients 18-90 years old of both genders, * Residence \> 2500m of altitude * diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) \>20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines * Patients stable on therapy * New York Heart Association (NYHA) functional class I-III * Provided 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 \< 2500m. * 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 have persistent oxygen saturation by pulse-oximetry (SpO2) \<80% on ambient air. * Patients with chronic mountain sickness (Hemoglobin \> 19 g/dl in women, \>21 g/dl in men) * 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 artery Pressure (PAP) in the morning of second day at sea level (LA) | in the morning of the second day at sea level | Change in PAP in mmHg assessed by echocardiography between LA (sea level) vs High altitude (HA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac output in the morning of the third day at sea level | in the morning of the third day at sea level | Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840m) |
| Tricuspid pressure gradient by echocardiography in the morning of the second day at sea level | in the morning of the second day at sea level | Tricuspid pressure gradient assessed by echocardiography between LA (sea level) vs HA (2840m) |
| Tricuspid pressure gradient by echocardiography in the morning of the third day at sea level | in the morning of the third day at sea level | Tricuspid pressure gradient assessed by echocardiography assessed by between LA (sea level) vs HA (2840m) |
| Tricupsid annular plane systolic excursion by echocardiography in the morning of the second day at sea level | in the morning of the third day at sea level | Tricupsid annular plane systolic excursion assessed by echocardiography assessed by between LA (sea level) vs HA (2840m) |
| Cardiac output in the morning of the second day at sea level | in the morning of the second day at sea level | Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840 m) |
| ph by arterial blood gases in the morning of the second day at sea level | in the morning of the second day at sea level | Change in ph by arterial blood gases assessed between LA (sea level) vs HA (2840m) |
| partial pressure of oxygen (PaO2) by arterial blood gases in the morning of the second day at sea level | in the morning of the second day at sea level | Change in partial pressure of oxygen (PaO2) assessed by arterial blood gases between LA (sea level) vs HA (2840m) |
| partial pressure of carbon dioxide (PaCO2) by arterial blood gases in the morning of the second day at sea level | in the morning of the second day at sea level | Change in partial pressure of carbon dioxide (PaCO2) assessed by arterial blood gases partial pressure of carbon dioxide (PaCO2) between LA (sea level) vs HA (2840m) |
| Tricupsid annular plane systolic excursion by echocardiography in the morning of the third day at sea level | in the morning of the third day at sea level | Tricupsid annular plane systolic excursion by echocardiography assessed by between LA (sea level) vs HA (2840m) |
Countries
Switzerland
Outcome results
None listed