HA Residents With PVD, Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) With and Without Supplemental Oxygen Therapy (SOT)

Study Overview
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Brief Summary
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To study the effect of SOT 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 by echocardiography and in relation to blood gases at 2840m with and without SOT.

Detailed Description
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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 echocardiografy to assess PAP, cardiac output and other hemodynamics and arterial blood gas to assess SaO2, PaO2 and PaCO2 near their living altitude in Quito at 2840m whilst breathing ambient air or SOT at 10l/min flow via a face mask with reservoir.

Official Title
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Effect of Supplemental Oxygen Therapy (SOT) 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 by Echocardiography

Conditions
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Pulmonary Vascular Disorder, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension

Intervention / Treatment
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* Other: Supplemental oxygen therapy
* Other: Sham Oxygen therapy


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 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 pulseoximetry (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: 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each participant works as its own perfect control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo (ambient hypoxic air at 2840m)<br>Ambient hypoxic air at 2840 m will be applied via a facial mask with reservoir | Other: Sham Oxygen therapy<br>* Patients will reveice pressurized air via a nasal cannula<br>* Other names: Placebo;|
| Experimental: SOT (high flow supplemental oxygen therapy)<br>SOT (supplemental oxygen therapy) at a flow of 10 l/min will be applied via a facial mask with reservoir | Other: Supplemental oxygen therapy<br>* Mobile oxygen via pressurized bottle or mobile oxygen concentrator will be applied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pulmonary Artery Pressure with SOT vs. placebo | Change in PAP in mmHg assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiac Output with SOT vs. placebo | Change in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen | 
| Change in right to left heart diameter ratio with SOT vs. placebo | Change in right to left heart diameter ratio assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen | 
| Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo | Change in tricuspid annular plane systolic excursion (TAPSE) with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen | 
| Change in right atrial area with SOT vs. placebo | Change in right atrial area by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen | 
| Change in right heart strain with SOT vs. placebo | Change in in right heart strain by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen | 
| Change in ph by arterial blood gases with SOT vs. placebo | Changes in ph by arterial blood gases SaO2, PaO2, PaCO2 with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen | 
| Change in PaO2 by arterial blood gases with SOT vs. placebo | Changes in PaO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen | 
| Change in PaCO2 by arterial blood gases with SOT vs. placebo | Changes in PaCO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary hypertension, hypoxia, supplemental oxygen, 6-minute walk distance