- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165019
Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.
August 15, 2019 updated by: University of Zurich
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
165
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
-
-
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Bishkek, Kyrgyzstan, 720040
- National Center for Cardiology and Internal Medicine
-
-
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
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in pulmonary artery pressure
Time Frame: Year 2012 to 2017
|
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
|
Year 2012 to 2017
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in nocturnal arterial oxygen saturation
Time Frame: Year 2012 to 2017
|
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
|
Year 2012 to 2017
|
Survival
Time Frame: Year 2012 to 2017
|
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
|
Year 2012 to 2017
|
Progression of oxygen desaturation index
Time Frame: Year 2012 to 2017
|
Difference in the change in the oxygen desaturation index 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
|
Year 2012 to 2017
|
Progression of quality of life
Time Frame: Year 2012 to 2017
|
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
|
Year 2012 to 2017
|
Progression of cognitive performance
Time Frame: Year 2012 to 2017
|
Difference in the change in the mean reaction time 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
|
Year 2012 to 2017
|
Exercise performance
Time Frame: Year 2012 to 2017
|
Difference in the change in 6 minute walk distance 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
|
Year 2012 to 2017
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Arterial blood gas analysis
Time Frame: Year 2012 to 2017
|
Difference in the change in arterial blood gases 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
|
Year 2012 to 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Talant M Sooronbaev, MD, NCCIM
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)
May 24, 2017
Primary Completion (ACTUAL)
August 16, 2017
Study Completion (ACTUAL)
August 16, 2017
Study Registration Dates
First Submitted
May 22, 2017
First Submitted That Met QC Criteria
May 22, 2017
First Posted (ACTUAL)
May 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 16, 2019
Last Update Submitted That Met QC Criteria
August 15, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-8/433
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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