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

Effect of Supplemental Oxygen Therapy (SOT) on 6-minute Walk Distance (6MWD) in Highlanders With High Altitude Pulmonary Hypertension Permanently Living at >2500m

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.

Study Overview

• Status: Completed
• Conditions: High Altitude Pulmonary Hypertension
• Intervention / Treatment: Other: 6-minute walk test (6MWT)

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 perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m with and without portable pulsed supplemental oxygen therapy (SOT) via nasal cannula according to a randomized cross-over design.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kyrgyzstan
  • Naryn Region
    • Aksay Plateau, Naryn Region, Kyrgyzstan
      • Aksay Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ambient air; Highlanders with HAPH will perform the 6 MWT on ambient air at 3200 m	Other: 6-minute walk test (6MWT); 6-minute walk test (6MWT) will be performed according to clinical standards
Experimental: SOT via nasal canula; 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); 6-minute walk test (6MWT) will be performed according to clinical standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m	Change of the arterial oxygen saturation by pulse oximetry (SpO2) at rest and at end of the 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	Change of the heart rate at rest and at end of the 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	Change of the blood pressure at rest and at end of the 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	Change of the Borg CR10 dyspnea scale at end of the 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	Change of the Borg CR10 leg fatigue scale at end of the 6MWT with SOT vs. ambient air at 3200 m	after 6 minute

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Silvia Ulrich, Prof. Dr., University Hospital Zurich, Department of Pulmonology; Principal Investigator: Talant MA Sooronbaev, Prof. Dr., National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pulmonary Hypertension; Hypoxia; High Altitude; 6-Minute Walk Test; Supplemental Oxygen Therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Hypertension; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia; Hypertension, Pulmonary; Altitude Sickness; Pulmonary edema of mountaineers
• Other Study ID Numbers: HAPH_SOT_6MWT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No