High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Study of Pulmonary Artery Pressure (PAP) and Other Hemodynamics Assessed by Echocardiography in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level

Conditions
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Pulmonary Vascular Disease, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension

Intervention / Treatment
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* Behavioral: Relocation from HA to LA


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will be investigated at high altitude (HA, 2840m) and low altitude (LA, sea level)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Investigations at High altitude (HA, 2840m)<br>PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m | Behavioral: Relocation from HA to LA<br>* Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes<br>|
| Experimental: Investigations at Low altitude (LA, sea level)<br>PAP and other hemodynamics assessed by echocardiography and blood gases after the first and second night at LA (sea level) | Behavioral: Relocation from HA to LA<br>* Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary artery Pressure (PAP) in the morning of second day at sea level (LA) | Change in PAP in mmHg assessed by echocardiography between LA (sea level) vs High altitude (HA) | in the morning of the second day at sea level | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output 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) | in the morning of the second day at sea level | 
| Cardiac output 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) | in the morning of the third day at sea level | 
| Tricuspid pressure gradient by echocardiography in the morning of the second day at sea level | Tricuspid pressure gradient assessed by echocardiography between LA (sea level) vs HA (2840m) | in the morning of the second day at sea level | 
| Tricuspid pressure gradient by echocardiography 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) | in the morning of the third day at sea level | 
| Tricupsid annular plane systolic excursion by echocardiography in the morning of the second day at sea level | Tricupsid annular plane systolic excursion assessed by echocardiography assessed by between LA (sea level) vs HA (2840m) | in the morning of the third day at sea level | 
| Tricupsid annular plane systolic excursion by echocardiography 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) | in the morning of the third day at sea level | 
| ph by arterial blood gases 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) | in the morning of the second day at sea level | 
| partial pressure of oxygen (PaO2) by arterial blood gases 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) | in the morning of the second day at sea level | 
| partial pressure of carbon dioxide (PaCO2) by arterial blood gases 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) | in the morning of the second day at sea level | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary hypertension, Pulmonary Vascular Disease, Chronic Thromboembolic Pulmonary Hypertension, high altitude, hypoxia, pulmonary artery pressure, arterial blood gases