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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03165019
Enrollment
165
Registered
2017-05-24
Start date
2017-05-24
Completion date
2017-08-16
Last updated
2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Altitude Pulmonary Hypertension, Sleep Apnea

Keywords

high altitude illness, pulmonary hypertension, sleep apnea, disease progression, hypoxia

Brief 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.

Interventions

None listed

Sponsors

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
CollaboratorOTHER_GOV
University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in pulmonary artery pressureYear 2012 to 2017Difference 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

MeasureTime frameDescription
SurvivalYear 2012 to 2017Cumulative 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 indexYear 2012 to 2017Difference 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 lifeYear 2012 to 2017Difference 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
Changes in nocturnal arterial oxygen saturationYear 2012 to 2017Difference in the change in the nocturnal arterial oxygen saturation 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Exercise performanceYear 2012 to 2017Difference 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 analysisYear 2012 to 2017Difference in the change in arterial blood gases 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Progression of cognitive performanceYear 2012 to 2017Difference in the change in the mean reaction time 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

Countries

Kyrgyzstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026