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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

NCT06092424•University of Zurich

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

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)

Locations (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, Switzerland

Key Dates

Start Date

September 23, 2023

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2024

Last Updated

October 23, 2023

Enrollment

ESTIMATED participants

Conditions

Pulmonary Vascular DiseasePulmonary Arterial HypertensionChronic Thromboembolic Pulmonary Hypertension

Interventions

Relocation from HA to LA

BEHAVIORAL

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

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RECRUITINGPHASE3

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

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Pulmonary Arterial Hypertension

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RECRUITING

Pulmonary Hypertension in Left Heart Disease

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Pulmonary Hypertension in Left Heart Disease

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume