HA Residents With PVD, SDB 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 sleep disordered breathing

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 nocturnal respiratory sleep studies near their living altitude in Quito at 2840m and at sea level in Pedernales during the first and the second night after relocation.

Official Title
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Comparative Study of Sleep Disordered Breathing (SDB) 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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* Other: Assessment without intervention at High altitude
* Other: Relocation to sea level for 2 days


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 cigarettes/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 2840m and after relocation to sea level
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Respiratory sleep study at 2840m<br>Participants will have a respiratory sleep study by polygraphy near their resident altitude at 2840m | Other: Assessment without intervention at High altitude<br>* Assessments at High altitude corresponding to Baseline measures<br>|
| Experimental: Respiratory sleep study near sea level (0-30m)<br>Participants will have a respiratory sleep study by polygraphy near sea level (0-30m) | Other: Relocation to sea level for 2 days<br>* Participants will be relocated to sea level and intervention and have assessements there.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean nocturnal SpO2 at LA vs. HA | Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m) | during the first night at low altitude (of intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean nocturnal SpO2 at LA vs. HA | Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m) | during the second night at low altitude (of intervention) | 
| Time spent with SpO2<90% at LA vs. HA | Change in time spent with SpO2<90% between LA (sea level) vs HA (2840 m) | during the first and second night at low altitude (of intervention) | 
| AHI at LA vs. HA | Change in apnea-hypopnea index (AHI) between LA (sea level) vs HA (2840 m) | during the first and second night at low altitude (of intervention) | 
| ODI at LA vs. HA | Change in oxygen desaturation index (ODI) between LA (sea level) vs HA (2840 m) | during the first and second night at low altitude (of intervention) | 
| Time spent with periodic breathing at LA vs. HA | Change in time spent with periodic breathingbetween LA (sea level) vs HA (2840 m) | during the first and second night at low altitude (of intervention) | 
| Heart rate variability at LA vs. HA | Change in heart rate variability between LA (sea level) vs HA (2840 m) | during the first and second night at low altitude (of intervention) | 
| ECG markers of repolarization at LA vs. HA | Change in electrocardiogram (ECG) markers of repolarization (QT time) between LA (sea level) vs HA (2840 m) | during the first and second night at low altitude | 
| pulse transit time drops at LA vs. HA | Change in pulse transit time drops between LA (sea level) vs HA (2840 m) | during the first and second night at low altitude | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Hypertension, Hypoxia, sleep disordered breathing, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude