Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.

NCT03165019 — Completed, 165 participants, University of Zurich

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Registry	NCT03165019
Status	Completed
Study type	Observational
Enrollment	165 (Actual)
Sponsor	University of Zurich (Other); collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Conditions	High Altitude Pulmonary Hypertension, Sleep Apnea
Dates	start 2017-05-24, primary completion 2017-08-16, completion 2017-08-16, first posted 2017-05-24, last updated 2019-08-16
Locations	1 site in Kyrgyzstan

-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. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

Changes in pulmonary artery pressure [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

Secondary outcomes

Changes in nocturnal arterial oxygen saturation [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
Survival [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
Progression of oxygen desaturation index [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
Progression of quality of life [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
Progression of cognitive performance [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
Exercise performance [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
Arterial blood gas analysis [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

+Eligibility

Sex: All, ages: 16 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
National Center for Cardiology and Internal Medicine	Bishkek	Kyrgyzstan

+Investigators

Talant M Sooronbaev, MD, Principal investigator, NCCIM

My Notes

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