Highlanders With High Altitude Pulmonary Hypertension (HAPH), 6 Minute Walk Distance (6MWD) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)

NCT06489743 | Completed

• 1 other identifier: HAPH_SOT_6MWT
• Study Type: interventional
• Target: 24
• 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 6-minute walk distance (6MWD) assessed at 3200m.

Conditions

High Altitude Pulmonary Hypertension

Keywords

Pulmonary Hypertension; Hypoxia; High Altitude; Supplemental Oxygen Therapy; 6-Minute Walk Test

Outcome Measures

Primary Outcomes (1)

• 6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m

  Change in 6MWD in meters between SOT vs. ambient air at 3200 m

  after 6 minute

Secondary Outcomes (5)

• SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m

  after 6 minute

• Heart rate at rest and end 6MWT with SOT vs. ambient air at 3200 m

  after 6 minute

• Blood pressure at rest and end 6MWT with SOT vs. ambient air at 3200 m

  after 6 minute

• Borg Dyspnea scale at end 6MWT with SOT vs. ambient air at 3200 m

  after 6 minute

• Borg leg fatigue scale at end 6MWT with SOT vs. ambient air at 3200 m

  after 6 minute

Study Arms (2)

Ambient air

ACTIVE COMPARATOR

Highlanders with HAPH will perform the 6 MWT on ambient air at 3200 m

Other: 6-minute walk test (6MWT)

SOT via nasal canula

EXPERIMENTAL

Portable pulsed supplemental oxygen therapy (SOT) will be provided via a nasal cannula from a regular portable oxygen concentrator carried on the back according to standard care

Other: 6-minute walk test (6MWT)

Interventions

6-minute walk test (6MWT) OTHER

6-minute walk test (6MWT) will be performed according to clinical standards

Ambient air; SOT via nasal canula

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 Region, 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: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each highlander with HAPH will perform a 6 MWT 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: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

KY (1)