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

NCT06092424 | Unknown

• 1 other identifier: PVD_HAvsLA_PAP
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pulmonary hypertension; Pulmonary Vascular Disease; Chronic Thromboembolic Pulmonary Hypertension; high altitude; hypoxia; pulmonary artery pressure; arterial blood gases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Cardiac output in the morning of the second day at sea level

  in the morning of the second day at sea level

• Cardiac output in the morning of the third day at sea level

  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

  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

  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

  in the morning of the third day at sea level

Study Arms (2)

Investigations at High altitude (HA, 2840m)

ACTIVE COMPARATOR

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

Behavioral: Relocation from HA to LA

Investigations at Low altitude (LA, sea level)

EXPERIMENTAL

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

Interventions

Relocation from HA to LA BEHAVIORAL

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

Investigations at High altitude (HA, 2840m); Investigations at Low altitude (LA, sea level)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Altitude Sickness; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be investigated at high altitude (HA, 2840m) and low altitude (LA, sea level)

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: October 23, 2023
• Study Start: September 23, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)