High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT)

Effect of Supplemental Oxygen Therapy (SOT) 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)

The investigators aim to study the effect of SOT in participants 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) assessed at 2840m.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Vascular Disease
• Intervention / Treatment: Other: 6-minute walk distance (6MWD) test; Other: 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)

Detailed Description

Participants 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 with and without SOT at 3l/min via nasal cannula according to a randomized cross-over design.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

IInclusion 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 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 pulseoximetry (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: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOT via nasal canula; Supplemental oxygen therapy (SOT) at 3l/min will be provided via a nasal cannula from a small oxygen bottle carried on the back according to standard care	Other: 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal); 6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (3l/min, nasal)
Active Comparator: Ambient air; Patient will perform tests on ambient air at 2840 m	Other: 6-minute walk distance (6MWD) test; 6-minute walk distance (6MWD) test will be performed according to clinical standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m	Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m	after 6 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m	Change of the arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m	6 minutes
Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m	Change of heart rate (bpm) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m	6 minutes
Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m	Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m	6 minutes
Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m	Change of Borg dyspnea scale at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m	6 minutes

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

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 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; Pulmonary arterial hypertension; High altitude; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary vascular disease; Supplemental Oxygen Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Vascular Diseases; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: PVD_HA_SOT_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