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High Altitude Pulmonary HypertensionNCT06489691

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

A study testing 6-minute walk test (6MWT) in people with High Altitude Pulmonary Hypertension, run by University of Zurich at 1 site in Kyrgyzstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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) Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
High Altitude Pulmonary Hypertension
What is being tested?
6-minute walk test (6MWT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteKyrgyzstan
Study dates
2 Jul 2024to 27 Sep 2024
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Kyrgyzstan1 site

  • Aksay Medical Center

    Aksay Plateau, Naryn, Kyrgyzstan

Other trials in Kyrgyzstan

About this study

Official 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

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)

Read the detailed description

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

Being tested
6-minute walk test (6MWT)
Keywords
Pulmonary Hypertension, Hypoxia, High Altitude, 6-Minute Walk Test
Medical subject headings
Pulmonary edema of mountaineers, Hypertension, Pulmonary, Hypoxia, Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6-minute walk test (6MWT)Other

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

Study groups in NCT06489691
Study groupRoleWhat they receive
Assessments at 3200 m and 760 m, respectivelyExperimentalParticipants will have a 6-minute walk distance (6MWD) assessment near their resident altitude at 3200 m and after relocation to 760 m after 1 and 7 days.
Receives: Other: 6-minute walk test (6MWT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-minute walk distance (6MWD) on day 2 of relocation to 760 m

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

    Measured: day 2 at 760 m compared to 3200 m

Secondary outcomes (11)

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

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

    Measured: day 7 at 760 m compared to 3200 m

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

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

    Measured: day 2 at 760 m compared to 3200 m

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

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

    Measured: day 7 at 760 m compared to 3200 m

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

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

    Measured: after the first night at LA (760 m)

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

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

    Measured: day 7 at 760 m compared to 3200 m

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

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

    Measured: day 2 at 760 m compared to 3200 m

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

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

    Measured: day 7 at 760 m compared to 3200 m

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

    Measured: day 2 at 760 m compared to 3200 m

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

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

    Measured: day 7 at 760 m compared to 3200 m

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

    Measured: day 2 at 760 m compared to 3200 m

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

    Measured: day 7 at 760 m compared to 3200 m

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2024
  2. Study start2 Jul 2024
  3. Primary completion27 Sep 2024
  4. Study completion27 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Each highlander with HAPH will perform a 6 MWT at 3200 m and at 760 m according to a prospective study design
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06489691
Sponsor's protocol ID
HAPH_HAvsLA_6MWT
Status last verified
Jan 2026
First submitted
28 Jun 2024
Last updated
22 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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