High Altitude Pulmonary HypertensionNCT03165019
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 at 1 site in Kyrgyzstan.
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 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Altitude Pulmonary Hypertension, Sleep Apnea
- How many people
- 165 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 24 May 2017to 16 Aug 2017
- How long will I take part?
- 5 Years
- Phase
- Observational
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 mean pulmonary artery pressure >30 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
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 participated in the study in 2012 to undergo follow-up examinations in 2017, in order to allow comparisons of current results with baseline data from 2012.
- 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 |
|---|---|---|
| High altitude pulmonary hypertension | Highlanders with high altitude pulmonary hypertension living above 2500 m. | |
| High altitude control | Healthy highlanders living above 2500 m. | |
| 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.
Changes in pulmonary artery pressure
Difference in the change in mean pulmonary artery pressure (mPAP measured by echocardiography) 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Measured: Year 2012 to 2017
Secondary outcomes (7)
Changes in nocturnal arterial oxygen saturation
Difference in the change in the nocturnal arterial oxygen saturation 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Measured: Year 2012 to 2017
Survival
Cumulative incidence of death and relocation to lower altitudes between 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Measured: Year 2012 to 2017
Progression of oxygen desaturation index
Difference in the change in the oxygen desaturation index 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Measured: Year 2012 to 2017
Progression of quality of life
Difference in the change in the mental and physical component score of the SF-36 questionnaire 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Measured: Year 2012 to 2017
Progression of cognitive performance
Difference in the change in the mean reaction time 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Measured: Year 2012 to 2017
Exercise performance
Difference in the change in 6 minute walk distance 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Measured: Year 2012 to 2017
Arterial blood gas analysis
Difference in the change in arterial blood gases 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Measured: Year 2012 to 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start24 May 2017
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
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.
- 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
- 165 participants (actual)
- Target duration
- 5 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, MD, Principal investigator, NCCIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165019
- Sponsor's protocol ID
- 01-8/433
- Status last verified
- Aug 2019
- First submitted
- 22 May 2017
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided