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NCT Number: NCT06489743

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

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.

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Key information

Conditions

High Altitude Pulmonary Hypertension Altitude Sickness Cardiovascular Diseases Hypertension Hypertension, Pulmonary Hypoxia Lung Diseases Pathological Conditions, Signs and Symptoms Pulmonary edema of mountaineers Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aksay Medical Center

Aksay Plateau, Naryn Region, Kyrgyzstan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

6-minute walk test (6MWT)

Other

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

Primary outcomes

  1. 6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m

    Time frame: after 6 minute

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

Secondary outcomes

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

    Time frame: after 6 minute

    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

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

    Time frame: after 6 minute

    Change of the heart rate at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m

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

    Time frame: after 6 minute

    Change of the blood pressure at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m

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

    Time frame: after 6 minute

    Change of the Borg CR10 dyspnea scale at end of the 6MWT with SOT vs. ambient air at 3200 m

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

    Time frame: after 6 minute

    Change of the Borg CR10 leg fatigue scale at end of the 6MWT with SOT vs. ambient air at 3200 m

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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