- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06489704
High Altitude (HA) Residents With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Artery Pressure (PAP) Assessed at HA (3200 m) vs LA (760 m)
January 19, 2026 updated by: University of Zurich
Comparative Study of Pulmonary Artery Pressure (PAP) Assessed by Echocardiography in Patients With High Altitude Pulmonary Hypertension (HAPH) Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200 m vs. at Low Altitude (LA) at 760 m
To study the effect of relocation from 3200 m (Aksay) to 760 m (Bishkek) in patients with high altitude pulmonary hypertension (HAPH) who permanently live >2500 m on pulmonary artery pressure (PAP)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 have pulmonary arterial pressure (PAP) assessed by echocardiography near their living altitude in Aksay at 3200 m and at 760 m in Bishkek the day after the first and the seventh night after relocation.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan, Kyrgyzstan
- Aksay Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Assessments at 3200 m and 760 m, respectively
Participants will have a echocardiography near their resident altitude at 3200 m and after relocation to 760 m after 1 and 7 days
|
Echocardiography will be performed according to clinical standards
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pulmonary artery Pressure (PAP) after the first night at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 2 at 760 m vs. 3200 m
|
Change in RV/RA in mmHg assessed by echocardiography between LA (760 m) vs High altitude (3200 m)
|
day 2 at 760 m vs. 3200 m
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pulmonary artery Pressure (PAP) after seven nights at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 7 at 760 m vs. 3200 m
|
Change in RV/RA in mmHg assessed by echocardiography between LA (760 m) vs High altitude (3200 m)
|
day 7 at 760 m vs. 3200 m
|
|
Cardiac output at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 2 and 7 at 760 m vs. 3200 m
|
Change in cardiac output in l/min assessed by echocardiography between LA (760 m) vs HA (3200 m)
|
day 2 and 7 at 760 m vs. 3200 m
|
|
Tricuspid pressure gradient by echocardiography at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 2 and 7 at 760 m vs. 3200 m
|
Tricuspid pressure gradient assessed by echocardiography between LA (760 m) vs HA (3200 m)
|
day 2 and 7 at 760 m vs. 3200 m
|
|
Tricupsid annular plane systolic excursion by echocardiography at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 2 and 7 at 760 m vs. 3200 m
|
Tricupsid annular plane systolic excursion assessed by echocardiography between LA (760 m) vs HA (3200 m)
|
day 2 and 7 at 760 m vs. 3200 m
|
|
pH by arterial blood gases at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 2 and 7 at 760 m vs. 3200 m
|
Change in pH by arterial blood gases assessed between LA (760 m) vs HA (3200 m)
|
day 2 and 7 at 760 m vs. 3200 m
|
|
partial pressure of oxygen (PaO2) by arterial blood gases at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 2 and 7 at 760 m vs. 3200 m
|
Change in partial pressure of oxygen (PaO2) assessed by arterial blood gases between LA (760 m) vs HA (3200 m)
|
day 2 and 7 at 760 m vs. 3200 m
|
|
partial pressure of carbon dioxide (PaCO2) by arterial blood gases at 760 m (LA) vs at 3200 m (HA)
Time Frame: after the first and seventh night at LA
|
Change in partial pressure of carbon dioxide (PaCO2) assessed by arterial blood gases partial pressure of carbon dioxide (PaCO2) between LA (760 m) vs HA (3200 m)
|
after the first and seventh night at LA
|
|
Change in right to left heart diameter ratio at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 2 and 7 at 760 m vs. 3200 m
|
Change in right to left heart diameter ratio assessed by echocardiography between LA (760 m) vs HA (3200 m)
|
day 2 and 7 at 760 m vs. 3200 m
|
|
Change in right atrial area at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 2 and 7 at 760 m vs. 3200 m
|
Change in right atrial area by echocardiography between LA (760 m) vs HA (3200 m)
|
day 2 and 7 at 760 m vs. 3200 m
|
|
Change in right heart strain at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 2 and 7 at 760 m vs. 3200 m
|
Change in right heart strain by echocardiography between LA (760 m) vs HA (3200 m)
|
day 2 and 7 at 760 m vs. 3200 m
|
|
Change in ECG morphology at 760 m (LA) vs at 3200 m (HA)
Time Frame: day 2 and 7 at 760 m vs. 3200 m
|
Change in ECG morphology and QT-interval by 12-lead ECG between LA (760 m) vs HA (3200 m)
|
day 2 and 7 at 760 m vs. 3200 m
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Silvia Ulrich, Prof. Dr., University Hospital Zurich, Department of Pulmonology
- Principal Investigator: Talant M Sooronbaev, Prof. Dr., National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2024
Primary Completion (Actual)
September 27, 2024
Study Completion (Actual)
September 27, 2024
Study Registration Dates
First Submitted
June 28, 2024
First Submitted That Met QC Criteria
June 28, 2024
First Posted (Actual)
July 8, 2024
Study Record Updates
Last Update Posted (Actual)
January 21, 2026
Last Update Submitted That Met QC Criteria
January 19, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAPH_HAvsLA_PAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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