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)

University of Zurich1 site in 1 country24 target enrollmentSeptember 23, 2023

ConditionsPulmonary Vascular Disease Pulmonary Artery Hypertension Chronic Thromboembolic Pulmonary Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Vascular Disease
Sponsor: University of Zurich
Enrollment: 24
Locations: 1
Primary Endpoint: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 23, 2023

End Date

December 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Zurich

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m

Time Frame: after 6 minute

Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m

Secondary Outcomes

SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m(6 minutes)
Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m(6 minutes)
Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m(6 minutes)
Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m(6 minutes)