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)

Not Applicable

Active, not recruiting

• Conditions: Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Vascular Disease; Pulmonary Artery Hypertension
• Interventions: Other: 6-minute walk distance (6MWD) test; Other: 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)

• Registration Number: NCT06003244
• Lead Sponsor: University of Zurich

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-21
• Study Start: 2023-09-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-05
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ambient air	6-minute walk distance (6MWD) test	Patient will perform tests on ambient air at 2840 m
SOT via nasal canula	6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m	6 minutes	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
Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m	6 minutes	Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m	6 minutes	Change of heart rate (bpm) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m	6 minutes	Change of Borg dyspnea scale at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m

Trial Locations

Locations (1)

University Hospital Zürich; 🇨🇭 Zürich, Switzerland