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

University of Zurich (UZH)

Status: Active, not recruiting

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

Treatments: Behavioral: Relocation from HA to LA

Study type: Interventional

Funder types: Other

Identifiers

NCT06092424

PVD_HAvsLA_PAP

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 pulmonary artery pressure (PAP) and other hemodynamics.

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 (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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Investigations at High altitude (HA, 2840m)

Active Comparator group

Description:

PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m

Treatment:

Behavioral: Relocation from HA to LA

Investigations at Low altitude (LA, sea level)

Experimental group

Description:

PAP and other hemodynamics assessed by echocardiography and blood gases after the first and second night at LA (sea level)

Treatment:

Behavioral: Relocation from HA to LA