HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)

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 6-minute walk distance (6MWD)

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 (PVDHA) will have 6-minute walk distance 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 6-minute Walk Distance (6MWD) 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 Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension

Intervention / Treatment
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* Behavioral: Relocation to sea level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients 18-80 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 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines Patients stable on therapy NYHA (new york heart association) 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 igarettes/day) Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen saturation by pulseoximetry) <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: 80 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 living permanently >2500m around Quito (Equador) will be assessed at 2850m and after relocation to sea level
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6-minute walk distance at 2840m<br>Participants will have 6-minute walk distance (6MWD) assessment near their resident altitude at 2840m | Behavioral: Relocation to sea level<br>* Relocation to sea level by bus and stay for 2 days<br>|
| Experimental: 6-minute walk distance at sea level<br>Participants will have 6-minute walk distance (6MWD) assessment at sea level (0-30m) | Behavioral: Relocation to sea level<br>* Relocation to sea level by bus and stay for 2 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk distance (6MWD) after the first night at LA | Change in 6MWD in meter between LA (sea level) vs HA (2840 m) | after the first night at LA (sea level) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk distance (6MWD) after the second night at LA | Change in 6MWD in meter between LA (sea level) vs HA (2840 m) | after the second night at LA (sea level) | 
| Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA | Change in SpO2 in % between LA (sea level) vs HA (2840 m) | after the first night at LA (sea level) | 
| Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA | Change in SpO2 in % between LA (sea level) vs HA (2840 m) | after the second night at LA (sea level) | 
| Heart rate at rest and at peak 6MWD after the first night at LA | Change in heart rate in bpm between LA (sea level) vs HA (2840 m) | after the first night at LA (sea level) | 
| Heart rate at rest and at peak 6MWD after the second night at LA | Change in heart rate in bpm between LA (sea level) vs HA (2840 m) | after the second night at LA (sea level) | 
| Blood pressure at rest and at peak 6MWD after the first night at LA | Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m) | after the first night at LA (sea level) | 
| Blood pressure at rest and at peak 6MWD after the second night at LA | Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m) | after the second night at LA (sea level) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Hypertension, Hypoxia, 6-minute walk test, High altitude, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension