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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06092424
• Other study ID #: PVD_HAvsLA_PAP
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 23, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Vascular Disease
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Switzerland	Respiratory Clinic, University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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