Effect of Supplemental Oxygen Therapy (SOT) on Pulmonary Arterial Pressure in Highlanders With High Altitude Pulmonary Hypertension Permanently Living at >2500m
| Registry | NCT06489756 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; non randomized, crossover, masking: none, other |
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| Enrollment | 48 (Actual) |
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| Sponsor | University of Zurich (Other) |
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| Conditions | High Altitude Pulmonary Hypertension |
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| Interventions | Echocardiography (Other) |
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| Dates | start 2024-07-01, primary completion 2024-12-31, completion 2024-12-31, first posted 2024-07-08, last updated 2025-12-04 |
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| Locations | 1 site in Kyrgyzstan |
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Related Papers Related Patents Related Grants Related Experts
All trials for High Altitude Pulmonary Hypertension All trials of Echocardiography
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Ambient air | Active comparator | Other: Echocardiography | Highlanders with HAPH will perform the echocardiography on ambient air at 3200m |
| 10 L/min SOT through face mask | Experimental | Other: Echocardiography | Supplemental oxygen therapy (SOT) at 10 L/min will be provided via face mask from oxygen concentrators |
- Echocardiography (Other): Echocardiography will be performed according to clinical standards
+Outcome measures
Primary outcomes
- Change in Pulmonary Artery Pressure with SOT vs.ambient air at 3200m [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 Cardiac Output with SOT vs. ambient air at 3200m [at 15 min of breathing ambient air or supplemental oxygen]: Change in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air at 3200m
- 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 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 3200m [at 15 min of breathing ambient air or supplemental oxygen]: Change 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 3200m [at 15 min of breathing ambient air or supplemental oxygen]: Change in right atrial area by echocardiography with SOT compared to ambient air at 3200m
- Change in right heart strain with SOT vs. ambient air at 3200m [at 15 min of breathing ambient air or supplemental oxygen]: Change in right heart strain by echocardiography with SOT compared to ambient air at 3200m
- Change in pH by arterial blood gases with SOT vs. ambient air at 3200m [at 15 min of breathing ambient air or supplemental oxygen]: Changes 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 3200m [at 15 min of breathing ambient air or supplemental oxygen]: Changes 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 3200m [at 15 min of breathing ambient air or supplemental oxygen]: Changes in PaCO2 by arterial blood gases with SOT compared to ambient air at 3200m
+Eligibility
Sex: All, ages: 18 Years to 80 Years
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)
+Locations (1)
| Facility | City | Country | Status |
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| Aksay Medical Center | Aksay Plateau, Naryn, Kyrgyzstan | Kyrgyzstan | |
+Publications
- Results publication: Vella A, Muller J, Omuralieva A, Titz A, Mayer L, Mademilov M, Lichtblau M, Furian M, Sooronbaev T, Ulrich S. Effects of high-dose supplemental oxygen therapy on pulmonary haemodynamics at 3250 m in high-altitude residents at risk for pulmonary hypertension. BMJ Open Respir Res. 2026 Oct 1;13(1):e004376. doi: 10.1136/bmjresp-2026-004376. PMID 42823120
+Investigators