Skip to main content
OpenTrials
Completed

NCT Number: NCT06489756

Highlanders With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Arterial Pressure (PAP) 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 pulmonary arterial pressure (PAP) assessed at 3200 m.

Completed

Looking for future studies?

Notify Me

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, Kyrgyzstan, 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 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.

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

echocardiography

Other

Echocardiography will be performed according to clinical standards

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in Cardiac Output with SOT vs. ambient air at 3200m

    Time frame: 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

  2. Change in right to left heart diameter ratio with SOT vs.ambient air at 3200m

    Time frame: 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

  3. Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs.ambient air at 3200m

    Time frame: 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

  4. Change in right atrial area with SOT vs. ambient air at 3200m

    Time frame: 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

  5. Change in right heart strain with SOT vs. ambient air at 3200m

    Time frame: 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

  6. Change in pH by arterial blood gases with SOT vs. ambient air at 3200m

    Time frame: 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

  7. Change in PaO2 by arterial blood gases with SOT vs. ambient air at 3200m

    Time frame: 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

  8. Change in PaCO2 by arterial blood gases with SOT vs. ambient air at 3200m

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Effect of Supplemental Oxygen Therapy (SOT) on Pulmonary Arterial Pressure 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
Dec 4, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.