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

Not Applicable

Not yet recruiting

• Conditions: High Altitude Pulmonary Hypertension
• Interventions: Other: Echocardiography

• Registration Number: NCT06489756
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study Start: 2024-07-01
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

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

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ambient air	Echocardiography	Highlanders with HAPH will perform the echocardiography on ambient air at 3200m
10 L/min SOT through face mask	Echocardiography	Supplemental oxygen therapy (SOT) at 10 L/min will be provided via face mask from oxygen concentrators

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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
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

Trial Locations

Locations (1)

Aksay Medical Center; 🇰🇬 Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan