HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)

Comparative Study of 6-minute Walk Distance (6MWD) 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 6-minute walk distance (6MWD)

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Vascular Disease
• Intervention / Treatment: Behavioral: Relocation to sea level

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 (PVDHA) will have 6-minute walk distance 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): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zürich

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adult patients 18-80 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 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
• Patients stable on therapy
• NYHA (new york heart association) 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 igarettes/day)
• Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen saturation by pulseoximetry) <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: 6-minute walk distance at 2840m; Participants will have 6-minute walk distance (6MWD) assessment near their resident altitude at 2840m	Behavioral: Relocation to sea level; Relocation to sea level by bus and stay for 2 days
Experimental: 6-minute walk distance at sea level; Participants will have 6-minute walk distance (6MWD) assessment at sea level (0-30m)	Behavioral: Relocation to sea level; Relocation to sea level by bus and stay for 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk distance (6MWD) after the first night at LA	Change in 6MWD in meter between LA (sea level) vs HA (2840 m)	after the first night at LA (sea level)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk distance (6MWD) after the second night at LA	Change in 6MWD in meter between LA (sea level) vs HA (2840 m)	after the second night at LA (sea level)
Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA	Change in SpO2 in % between LA (sea level) vs HA (2840 m)	after the first night at LA (sea level)
Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA	Change in SpO2 in % between LA (sea level) vs HA (2840 m)	after the second night at LA (sea level)
Heart rate at rest and at peak 6MWD after the first night at LA	Change in heart rate in bpm between LA (sea level) vs HA (2840 m)	after the first night at LA (sea level)
Heart rate at rest and at peak 6MWD after the second night at LA	Change in heart rate in bpm between LA (sea level) vs HA (2840 m)	after the second night at LA (sea level)
Blood pressure at rest and at peak 6MWD after the first night at LA	Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)	after the first night at LA (sea level)
Blood pressure at rest and at peak 6MWD after the second night at LA	Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)	after the second night at LA (sea level)

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Silvia Ulrich, Prof. Dr., University Hospital Zurich, Departement of Pulmonology; Principal Investigator: Rodrigo Hoyos, Dr., Carlos Adrade Marin Hospital of Quito, Equador

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary Hypertension; Hypoxia; 6-minute walk test; High altitude; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Artery Hypertension
• 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_6MWD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

Drug and device information, study documents

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