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

Not Applicable

Active, not recruiting

• Conditions: Pulmonary Vascular Disease; Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension
• Interventions: Behavioral: Relocation from HA to LA

• Registration Number: NCT06092424
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study First Submitted: 2023-08-09
• Study Start: 2023-09-23
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Investigations at High altitude (HA, 2840m)	Relocation from HA to LA	PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m
Investigations at Low altitude (LA, sea level)	Relocation from HA to LA	PAP and other hemodynamics assessed by echocardiography and blood gases after the first and second night at LA (sea level)

Primary Outcome Measures

Name	Time	Method
Pulmonary artery Pressure (PAP) in the morning of second day at sea level (LA)	in the morning of the second day at sea level	Change in PAP in mmHg assessed by echocardiography between LA (sea level) vs High altitude (HA)

Secondary Outcome Measures

Name	Time	Method
Tricuspid pressure gradient by echocardiography in the morning of the second day at sea level	in the morning of the second day at sea level	Tricuspid pressure gradient assessed by echocardiography between LA (sea level) vs HA (2840m)
Tricuspid pressure gradient by echocardiography in the morning of the third day at sea level	in the morning of the third day at sea level	Tricuspid pressure gradient assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)
Cardiac output in the morning of the second day at sea level	in the morning of the second day at sea level	Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840 m)
Cardiac output in the morning of the third day at sea level	in the morning of the third day at sea level	Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840m)
Tricupsid annular plane systolic excursion by echocardiography in the morning of the second day at sea level	in the morning of the third day at sea level	Tricupsid annular plane systolic excursion assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)
Tricupsid annular plane systolic excursion by echocardiography in the morning of the third day at sea level	in the morning of the third day at sea level	Tricupsid annular plane systolic excursion by echocardiography assessed by between LA (sea level) vs HA (2840m)
ph by arterial blood gases in the morning of the second day at sea level	in the morning of the second day at sea level	Change in ph by arterial blood gases assessed between LA (sea level) vs HA (2840m)
partial pressure of oxygen (PaO2) by arterial blood gases in the morning of the second day at sea level	in the morning of the second day at sea level	Change in partial pressure of oxygen (PaO2) assessed by arterial blood gases between LA (sea level) vs HA (2840m)
partial pressure of carbon dioxide (PaCO2) by arterial blood gases in the morning of the second day at sea level	in the morning of the second day at sea level	Change in partial pressure of carbon dioxide (PaCO2) assessed by arterial blood gases partial pressure of carbon dioxide (PaCO2) between LA (sea level) vs HA (2840m)

Trial Locations

Locations (1)

Respiratory Clinic, University Hospital of Zurich; 🇨🇭 Zurich, Switzerland