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

University of Zurich (UZH)

Status: Active, not recruiting

Conditions: Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Vascular Disease

Treatments: Other: Assessment without intervention at High altitude; Other: Relocation to sea level for 2 days

Study type: Interventional

Funder types: Other

Identifiers

NCT06072417

PVD_HAvsLA_SDB

Details and patient eligibility

About

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

Full 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 (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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups, including a placebo group

Respiratory sleep study at 2840m

Placebo Comparator group

Description:

Participants will have a respiratory sleep study by polygraphy near their resident altitude at 2840m

Treatment:

Other: Assessment without intervention at High altitude

Respiratory sleep study near sea level (0-30m)

Experimental group

Description:

Participants will have a respiratory sleep study by polygraphy near sea level (0-30m)

Treatment:

Other: Relocation to sea level for 2 days