High Altitude Pulmonary HypertensionNCT06489730
HAPH Registry: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.
An observational study of High Altitude Pulmonary Hypertension and Sleep Apnea, run by University of Zurich.
Trial summary
The purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Altitude Pulmonary Hypertension, Sleep Apnea
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2024
- How long will I take part?
- 7 Years
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Highlanders living at Aksay plateau will be invited to participate.
Who may be able to join
- Permanently living >2500 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
No sites are listed yet.
About this study
The purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study. To this end, the investigators will invite the same highlanders who participate din the study in 2017 to undergo follow-up examinations in 2024, in order to allow comparisons of current results with baseline data from 2017.
- Conditions
- High Altitude Pulmonary Hypertension, Sleep Apnea
- Keywords
- high altitude illness, pulmonary hypertension, sleep apnea, disease progression, hypoxia
- Medical subject headings
- Pulmonary edema of mountaineers, Sleep Apnea Syndromes, Hypertension, Pulmonary, Disease Progression, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Highlanders living above 2500 m | Highlanders permanently living above 2500 m in the Aksay area in Kyrgyzstan | |
| Low altitude control | Healthy lowlanders living below 1000 m. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary artery pressure in highlanders
Change in pulmonary artery pressure (RV/RA measured by echocardiography) from 2017 to 2024 in highlanders living above 2500 m.
Measured: Year 2017 to 2024
Secondary outcomes (6)
Change in pulmonary artery pressure between highlanders and lowlanders
Difference in the change in pulmonary artery pressure (RV/RA measured by echocardiography) from 2017 to 2024 between highlanders and lowland controls.
Measured: Year 2017 to 2024
Change in TRP/CO in highlanders
Change in TRP/CO slope from 2017 to 2024 in highlanders living above 2500 m.
Measured: Year 2017 to 2024
Progression of oxygen desaturation index
Change in the oxygen desaturation index from 2017 to 2024 in highlanders.
Measured: Year 2017 to 2024
Progression of quality of life
Change in the mental and physical component score of the SF-36 questionnaire from 2017 to 2024 in highlanders.
Measured: Year 2017 to 2024
Progression of arterial blood gases
Change in the arterial blood gases from 2017 to 2024 in highlanders.
Measured: Year 2017 to 2024
Progression of right heart strain
Change in the right heart strain from 2017 to 2024 in highlanders.
Measured: Year 2017 to 2024
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 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Responsible party
- Sponsor
- Investigators
- Talant M 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
- NCT06489730
- Sponsor's protocol ID
- HAPH_Register
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAPH Registry: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.
- ClinicalTrials.gov ID
- NCT06489730
- Acronym / sponsor ID
- HAPH_Register
- Conditions
- High Altitude Pulmonary Hypertension, Sleep Apnea
- Keywords
- high altitude illness, pulmonary hypertension, sleep apnea, disease progression, hypoxia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- 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 purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study. To this end, the investigators will invite the same highlanders who participate din the study in 2017 to undergo follow-up examinations in 2024, in order to allow comparisons of current results with baseline data from 2017.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Highlanders living above 2500 m | – | –Highlanders permanently living above 2500 m in the Aksay area in Kyrgyzstan |
| Low altitude control | – | –Healthy lowlanders living below 1000 m. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Highlanders living at Aksay plateau will be invited to participate.
Key inclusion criteria (2 listed)
- Permanently living >2500 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.
Primary outcome
Change in pulmonary artery pressure in highlanders
Time frame: Year 2017 to 2024
Change in pulmonary artery pressure (RV/RA measured by echocardiography) from 2017 to 2024 in highlanders living above 2500 m.
6 secondary outcomes
Change in pulmonary artery pressure between highlanders and lowlanders
Time frame: Year 2017 to 2024
Change in TRP/CO in highlanders
Time frame: Year 2017 to 2024
Progression of oxygen desaturation index
Time frame: Year 2017 to 2024
Progression of quality of life
Time frame: Year 2017 to 2024
Progression of arterial blood gases
Time frame: Year 2017 to 2024
Progression of right heart strain
Time frame: Year 2017 to 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- 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
Not yet recruiting
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 M 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
Questions about this trial
What is this clinical trial studying?
An observational study of High Altitude Pulmonary Hypertension and Sleep Apnea, run by University of Zurich.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Ulrich, Prof. Dr. (+41442552220, silvia.ulrich@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary artery pressure in highlanders (time frame: Year 2017 to 2024). 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 8 Jul 2024.