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Completed

NCT Number: NCT06489691

High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), 6MWT Assessed at High Altitude (3200m) vs Low Altitude (760m)

To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live >2500m on 6-minute walk distance (6MWD)

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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, Kyrgyzstan, Kyrgyzstan

About this study

This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA >30 mmHg who permanently live at HA >2500 m will perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m and on day 2 and 7 at 760 m after relocation

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) on day 2 of relocation to 760 m

    Time frame: day 2 at 760 m compared to 3200 m

    Change in 6MWD in meter between LA (760 m) vs HA (3200 m)

Secondary outcomes

  1. 6-minute walk distance (6MWD) on day 7 of relocation to 760 m

    Time frame: day 7 at 760 m compared to 3200 m

    6-minute walk distance (6MWD) in meter between LA (760 m) and HA (3200 m)

  2. Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 2 of relocation to 760 m

    Time frame: day 2 at 760 m compared to 3200 m

    Change in SpO2 in % between LA (760 m) vs HA (3200 m)

  3. Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 7 of relocation to 760 m

    Time frame: day 7 at 760 m compared to 3200 m

    Change in SpO2 in % between LA (760 m) vs HA (3200 m)

  4. Heart rate at rest and at peak 6MWD on day 2 of relocation to 760 m

    Time frame: after the first night at LA (760 m)

    Change in hear rate in bpm between LA (760 m) vs HA (3200 m)

  5. Heart rate at rest and at peak 6MWD on day 7 of relocation to 760 m

    Time frame: day 7 at 760 m compared to 3200 m

    Change in hear rate in bpm between LA (760 m) vs HA (3200 m)

  6. Blood pressure at rest and at 6MWD on day 2 of relocation to 760 m

    Time frame: day 2 at 760 m compared to 3200 m

    Change in blood pressure in mmHg between LA (760 m) vs HA (3200 m)

  7. Blood pressure at rest and at 6MWD on day 7 of relocation to 760 m

    Time frame: day 7 at 760 m compared to 3200 m

    Change in blood pressure in mmHg between LA (760 m) vs HA (3200 m)

  8. Borg Dyspnea scale at end 6MWT on day 2 of relocation to 760 m

    Time frame: day 2 at 760 m compared to 3200 m

    Change of the Borg CR10 dyspnea scale at end of the 6MWT after the first night at LA (760 m) vs HA (3200 m)

  9. Borg Dyspnea scale at end 6MWT on day 7 of relocation to 760 m

    Time frame: day 7 at 760 m compared to 3200 m

    Change of the Borg CR10 dyspnea scale at end of the 6MWT after seven nights at LA (760 m) vs HA (3200 m)

  10. Borg leg fatigue scale at end 6MWT on day 2 of relocation to 760 m

    Time frame: day 2 at 760 m compared to 3200 m

    Change of the Borg CR10 leg fatigue scale at end of the 6MWT after the first night at LA (760 m) vs HA (3200 m)

  11. Borg leg fatigue scale at end 6MWT on day 7 of relocation to 760 m

    Time frame: day 7 at 760 m compared to 3200 m

    Change of the Borg CR10 leg fatigue scale at end of the 6MWT after seven nights at LA (760 m) vs HA (3200 m)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Comparative Study of 6-minute Walk Distance (6MWD) in Patients With High Altitude Pulmonary Hypertension Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200m vs. at Low Altitude (LA) 760m

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2024
Registry last updated
Jan 22, 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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