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

NCT06489756 | Completed

• 1 other identifier: HAPH_SOT_PAP
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

High Altitude Pulmonary Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  at 15 min of breathing ambient air or supplemental oxygen

Secondary Outcomes (8)

• Change in Cardiac Output 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 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 right heart strain with SOT vs. ambient air at 3200m

  at 15 min of breathing ambient air or supplemental oxygen

Study Arms (2)

Ambient air

ACTIVE COMPARATOR

Highlanders with HAPH will perform the echocardiography on ambient air at 3200m

Other: Echocardiography

10 L/min SOT through face mask

EXPERIMENTAL

Supplemental oxygen therapy (SOT) at 10 L/min will be provided via face mask from oxygen concentrators

Other: Echocardiography

Interventions

Echocardiography OTHER

Echocardiography will be performed according to clinical standards

10 L/min SOT through face mask; Ambient air

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Aksay Medical Center

Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan

Location

MeSH Terms

Conditions

Pulmonary edema of mountaineers; Hypertension, Pulmonary; Hypoxia; Altitude Sickness

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• Talant MA Sooronbaev, Prof. Dr.

  National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

  PRINCIPAL INVESTIGATOR

• Silvia Ulrich, Prof. Dr.

  University Hospital Zurich, Department of Pulmonology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

KY (1)