High Altitude Pulmonary HypertensionNCT06489743
Highlanders With High Altitude Pulmonary Hypertension (HAPH), 6 Minute Walk Distance (6MWD) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)
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.
Trial summary
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. 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
- 1 Jul 2024to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
About this study
Official title: 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.
Read the 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.
- Conditions
- High Altitude Pulmonary Hypertension
- Being tested
- 6-minute walk test (6MWT)
- Keywords
- Pulmonary Hypertension, Hypoxia, High Altitude, Supplemental Oxygen Therapy, 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 group | Role | What they receive |
|---|---|---|
| Ambient air | Active comparator | Highlanders with HAPH will perform the 6 MWT on ambient air at 3200 m Receives: Other: 6-minute walk test (6MWT) |
| SOT via nasal canula | Experimental | 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 Receives: Other: 6-minute walk test (6MWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 6 minute
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: after 6 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Jul 2024
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Altitude Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Model description
- Each highlander with HAPH will perform a 6 MWT with and without SOT according to a cross-over design.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Talant MA Sooronbaev, Prof. Dr., Principal investigator, National Center of Cardiology and Internal Medicine named after academician M.MirrakhimovSilvia Ulrich, Prof. Dr., Principal investigator, University Hospital Zurich, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489743
- Sponsor's protocol ID
- HAPH_SOT_6MWT
- Status last verified
- Jan 2026
- First submitted
- 28 Jun 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplemental Oxygen Therapy (SOT) on 6-minute Walk Distance (6MWD) in Highlanders With High Altitude Pulmonary Hypertension Permanently Living at >2500m
- ClinicalTrials.gov ID
- NCT06489743
- Acronym / sponsor ID
- HAPH_SOT_6MWT
- Conditions
- High Altitude Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Hypoxia, High Altitude, Supplemental Oxygen Therapy, 6-Minute Walk Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each highlander with HAPH will perform a 6 MWT with and without SOT according to a cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Ambient air | Active comparator | Other: 6-minute walk test (6MWT)Highlanders with HAPH will perform the 6 MWT on ambient air at 3200 m |
| SOT via nasal canula | Experimental | Other: 6-minute walk test (6MWT)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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walk test (6MWT)6-minute walk test (6MWT) will be performed according to clinical standards | Other | Ambient air, SOT via nasal canula |
Primary outcome
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
5 secondary outcomes
SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m
Time frame: after 6 minute
Heart rate at rest and end 6MWT with SOT vs. ambient air at 3200 m
Time frame: after 6 minute
Blood pressure at rest and end 6MWT with SOT vs. ambient air at 3200 m
Time frame: after 6 minute
Borg Dyspnea scale at end 6MWT with SOT vs. ambient air at 3200 m
Time frame: after 6 minute
Borg leg fatigue scale at end 6MWT with SOT vs. ambient air at 3200 m
Time frame: after 6 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for High Altitude Pulmonary Hypertension
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
High Altitude, Healthy Adult
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Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals
High Altitude, Healthy
Not yet recruiting
Assessment of Six-minute Walking Distance 6MWD Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talant MA Sooronbaev, Prof. Dr. principal investigator
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Silvia Ulrich, Prof. Dr. principal investigator
University Hospital Zurich, Department of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kyrgyzstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m (time frame: after 6 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.