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Highlanders With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Arterial Pressure (PAP) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06489756
Enrollment
48
Registered
2024-07-08
Start date
2024-07-01
Completion date
2024-12-31
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Altitude Pulmonary Hypertension

Keywords

Pulmonary Hypertension, Hypoxia, High Altitude, Supplemental Oxygen Therapy, Pulmonal Arterial Pressure

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.

Interventions

OTHEREchocardiography

Echocardiography will be performed according to clinical standards

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

Each highlander with HAPH will perform a echocardiography with and without SOT according to a cross-over design

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Pulmonary Artery Pressure with SOT vs.ambient air at 3200mat 15 min of breathing ambient air or supplemental oxygenChange in RV/RA in mmHg assessed by echocardiography with SOT compared to ambient air at 3200m

Secondary

MeasureTime frameDescription
Change in right to left heart diameter ratio with SOT vs.ambient air at 3200mat 15 min of breathing ambient air or supplemental oxygenChange in right to left heart diameter ratio assessed by echocardiography with SOT compared to ambient air at 3200m
Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs.ambient air at 3200mat 15 min of breathing ambient air or supplemental oxygenChange in tricuspid annular plane systolic excursion (TAPSE) with SOT compared to ambient air at 3200m
Change in right atrial area with SOT vs. ambient air at 3200mat 15 min of breathing ambient air or supplemental oxygenChange in right atrial area by echocardiography with SOT compared to ambient air at 3200m
Change in Cardiac Output with SOT vs. ambient air at 3200mat 15 min of breathing ambient air or supplemental oxygenChange in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air at 3200m
Change in pH by arterial blood gases with SOT vs. ambient air at 3200mat 15 min of breathing ambient air or supplemental oxygenChanges in pH by arterial blood gases with SOT compared to ambient air at 3200m
Change in PaO2 by arterial blood gases with SOT vs. ambient air at 3200mat 15 min of breathing ambient air or supplemental oxygenChanges in PaO2 by arterial blood gases with SOT compared to ambient air at 3200m
Change in PaCO2 by arterial blood gases with SOT vs. ambient air at 3200mat 15 min of breathing ambient air or supplemental oxygenChanges in PaCO2 by arterial blood gases with SOT compared to ambient air at 3200m
Change in right heart strain with SOT vs. ambient air at 3200mat 15 min of breathing ambient air or supplemental oxygenChange in right heart strain by echocardiography with SOT compared to ambient air at 3200m

Countries

Kyrgyzstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026