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

NCT ID: NCT06092424

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-23
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Investigations at High altitude (HA, 2840m)

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

Group Type: ACTIVE_COMPARATOR

Relocation from HA to LA

Intervention Type: BEHAVIORAL

Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes

Investigations at Low altitude (LA, sea level)

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

Group Type: EXPERIMENTAL

Relocation from HA to LA

Intervention Type: BEHAVIORAL

Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes

Interventions

Relocation from HA to LA

Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Respiratory Clinic, University Hospital of Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

PVD_HAvsLA_PAP

Identifier Type: -

Identifier Source: org_study_id