High Altitude Pulmonary HypertensionNCT01621061
Sleep Related Breathing Disturbances and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders
An observational study of High Altitude Pulmonary Hypertension and Sleep Apnea, run by University of Zurich at 1 site in Kyrgyzstan.
Trial summary
High altitude pulmonary hypertension, a form of altitude illness that occurs in long-term residents at altitudes >2500 m, is characterized by dyspnea, hypoxemia, impaired exercise performance and hypertension in the pulmonary circulation. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Altitude Pulmonary Hypertension, Sleep Apnea
- How many people
- 125 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- Jun 2012to Dec 2013
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Highlanders with high altitude pumonary hypertension living at an altitude of 2500-4000 m; healthy highlanders living at an altitude of 2500-4000 m; healthy lowlanders living at an altitude of <1000 m.
Who may be able to join
- high altitude pulmonary hypertension confirmed by clinical presentation and systolic pulmonary artery pressure >50 mmHg measured by echocardiography at altitude of residence.
- healthy subjects (high altitude controls)
- Both genders
- Age >16 y
- Kyrgyz ethnicity
- born, raised and currently living at >2500 m
- healthy subjects currently living at <1000 m (low altitude controls)
Who cannot join
- Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography
- excessive erythrocytosis
- other coexistent disorders that may interfere with the cardio-respiratory system and sleep
- regular use of medication that affects control of breathing
- heavy smoking
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site
National Center for Cardiology and Internal Medicine
Bishkek, 720040
About this study
Official title: Sleep Apnea and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders
High altitude pulmonary hypertension, a form of altitude illness that occurs in long-term residents at altitudes >2500 m, is characterized by dyspnea, hypoxemia, impaired exercise performance and hypertension in the pulmonary circulation. Whether sleep related breathing disturbances, common causes of nocturnal hypoxemia in lowlanders, are also prevalent in highlanders and promote pulmonary hypertension in highlanders is unknown. Therefore, the current study will investigate whether highlanders with high altitude pulmonary hypertension have a greater prevalence of sleep apnea than healthy highlanders and lowlanders.
- Conditions
- High Altitude Pulmonary Hypertension, Sleep Apnea
- Keywords
- high altitude illness, pulmonary hypertension, sleep apnea, hypoxia
- Medical subject headings
- Pulmonary edema of mountaineers, Sleep Apnea Syndromes, Hypertension, Pulmonary, 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 |
|---|---|---|
| High altitude pulmonary hypertension | Highlanders with high altitude pulmonary hypertension | |
| High altitude control | Healthy highlanders | |
| Low altitude control | Healthy lowlanders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep related breathing disturbances
Nocturnal oxygen saturation and apnea/hypopnea index
Measured: 4 months
Secondary outcomes (10)
Pulmonary artery pressure
Echocardiography
Measured: 4 months
Dyspnea
NYHA functional class
Measured: 4 months
Vigilance
Psychomotor vigilance
Measured: 4 months
Exercise performance
6 min walk test
Measured: 4 months
Pulmonary function
Spirometry
Measured: 4 months
Cerebral oxygen saturation
Near-infrared spectroscopy
Measured: 4 months
Mountain sickness
Quinghai chronic mountain sickness score
Measured: 4 months
Generic quality of life
SF-36 quality of life questionnaire
Measured: 4 months
Disease specific quality of life
Kansas City Cardiomyopathy questionnaire
Measured: 4 months
Subjective sleepiness
Epworth sleepiness scale
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
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
- Principal investigator, Konrad E. Bloch, University of Zurich
- Investigators
- Konrad E Bloch, MD, Principal investigator, University of Zurich, SwitzerlandTalant Sooronbaev, MD, Principal investigator, National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621061
- Sponsor's protocol ID
- 01-7/219
- Status last verified
- May 2014
- First submitted
- 13 Jun 2012
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders
- ClinicalTrials.gov ID
- NCT01621061
- Acronym / sponsor ID
- 01-7/219
- Conditions
- High Altitude Pulmonary Hypertension, Sleep Apnea
- Keywords
- high altitude illness, pulmonary hypertension, sleep apnea, hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Jun 2012 (estimated)
- 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.
High altitude pulmonary hypertension, a form of altitude illness that occurs in long-term residents at altitudes >2500 m, is characterized by dyspnea, hypoxemia, impaired exercise performance and hypertension in the pulmonary circulation. Whether sleep related breathing disturbances, common causes of nocturnal hypoxemia in lowlanders, are also prevalent in highlanders and promote pulmonary hypertension in highlanders is unknown. Therefore, the current study will investigate whether highlanders with high altitude pulmonary hypertension have a greater prevalence of sleep apnea than healthy highlanders and lowlanders.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High altitude pulmonary hypertension | – | –Highlanders with high altitude pulmonary hypertension |
| High altitude control | – | –Healthy highlanders |
| Low altitude control | – | –Healthy lowlanders |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Highlanders with high altitude pumonary hypertension living at an altitude of 2500-4000 m; healthy highlanders living at an altitude of 2500-4000 m; healthy lowlanders living at an altitude of <1000 m.
Key inclusion criteria (7 listed)
- high altitude pulmonary hypertension confirmed by clinical presentation and systolic pulmonary artery pressure >50 mmHg measured by echocardiography at altitude of residence.
- healthy subjects (high altitude controls)
- Both genders
- Age >16 y
- Kyrgyz ethnicity
Key exclusion criteria (5 listed)
- Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography
- excessive erythrocytosis
- other coexistent disorders that may interfere with the cardio-respiratory system and sleep
- regular use of medication that affects control of breathing
- heavy smoking
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
Sleep related breathing disturbances
Time frame: 4 months
Nocturnal oxygen saturation and apnea/hypopnea index
10 secondary outcomes
Pulmonary artery pressure
Time frame: 4 months
Dyspnea
Time frame: 4 months
Vigilance
Time frame: 4 months
Exercise performance
Time frame: 4 months
Pulmonary function
Time frame: 4 months
Cerebral oxygen saturation
Time frame: 4 months
Mountain sickness
Time frame: 4 months
Generic quality of life
Time frame: 4 months
Disease specific quality of life
Time frame: 4 months
Subjective sleepiness
Time frame: 4 months
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 15 May 2014.
Related trials for High Altitude Pulmonary Hypertension
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Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
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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
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Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals
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Assessment of Six-minute Walking Distance 6MWD Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
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Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
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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.
Konrad E Bloch, MD principal investigator
University of Zurich, Switzerland
Talant Sooronbaev, MD principal investigator
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
1 site in 1 country: see every site and its status.
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 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 7 inclusion and 5 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 15 May 2014. 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?
Sleep related breathing disturbances (time frame: 4 months). 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 15 May 2014.