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

Comparative Study of Pulmonary Artery Pressure (PAP) and Other Hemodynamics Assessed by Echocardiography 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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Vascular Disease
• Intervention / Treatment: Behavioral: Relocation from HA to LA

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Respiratory Clinic, University Hospital of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Investigations at High altitude (HA, 2840m); PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m	Behavioral: Relocation from HA to LA; Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes
Experimental: 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)	Behavioral: Relocation from HA to LA; Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output 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)	in the morning of the second day at sea level
Cardiac output 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)	in the morning of the third day at sea level
Tricuspid pressure gradient by echocardiography in the morning of the second day at sea level	Tricuspid pressure gradient assessed by echocardiography between LA (sea level) vs HA (2840m)	in the morning of the second day at sea level
Tricuspid pressure gradient by echocardiography 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)	in the morning of the third day at sea level
Tricupsid annular plane systolic excursion by echocardiography in the morning of the second day at sea level	Tricupsid annular plane systolic excursion assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)	in the morning of the third day at sea level
Tricupsid annular plane systolic excursion by echocardiography 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)	in the morning of the third day at sea level
ph by arterial blood gases 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)	in the morning of the second day at sea level
partial pressure of oxygen (PaO2) by arterial blood gases 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)	in the morning of the second day at sea level
partial pressure of carbon dioxide (PaCO2) by arterial blood gases 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)	in the morning of the second day at sea level

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pulmonary hypertension; hypoxia; high altitude; Chronic Thromboembolic Pulmonary Hypertension; pulmonary artery pressure; Pulmonary Vascular Disease; arterial blood gases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Vascular Diseases; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: PVD_HAvsLA_PAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request to the PI and after publication of results, data will be shared upon reasonable research questions and ethical approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No