Effect of Supplemental Oxygen Therapy (SOT) on Pulmonary Arterial Pressure in Highlanders With High Altitude Pulmonary Hypertension Permanently Living at >2500m

University of Zurich1 site in 1 country48 target enrollmentJuly 1, 2024

ConditionsHigh Altitude Pulmonary Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: High Altitude Pulmonary Hypertension
Sponsor: University of Zurich
Enrollment: 48
Locations: 1
Primary Endpoint: Change in Pulmonary Artery Pressure with SOT vs.ambient air at 3200m
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live >2500m on pulmonary arterial pressure (PAP) assessed at 3200 m.

Detailed Description

Highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA (Tricuspid Regurgitation Pressure Gradient) \>30 mmHg will be recruited for this project. Highlanders permanently living at HA \>2500 m will have echocardiografy to assess PAP near their living altitude in Aksay at 3200 m with and without 10L/min supplemental oxygen therapy (SOT) via face mask.

Registry

clinicaltrials.gov

Start Date

July 1, 2024

End Date

December 31, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Zurich

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Permanently living \>2500 m
•HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
•Written informed consent

Exclusion Criteria

•Highlanders who cannot follow the study investigations,
•Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, heavy smoking \>20 cigarettes/day or \>20 pack-years.
•Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
•Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)

Outcomes

Primary Outcomes

Change in Pulmonary Artery Pressure with SOT vs.ambient air at 3200m

Time Frame: at 15 min of breathing ambient air or supplemental oxygen

Change in RV/RA in mmHg assessed by echocardiography with SOT compared to ambient air at 3200m

Secondary Outcomes

Change in right heart strain with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
Change in Cardiac Output with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs.ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
Change in right atrial area with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
Change in pH by arterial blood gases with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
Change in right to left heart diameter ratio with SOT vs.ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
Change in PaCO2 by arterial blood gases with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)
Change in PaO2 by arterial blood gases with SOT vs. ambient air at 3200m(at 15 min of breathing ambient air or supplemental oxygen)