Cerebral Tissue Oxygenation in Highlanders/Lowlanders

Completed

• Conditions: High Altitude Pulmonary Hypertension

• Registration Number: NCT03172429
• Lead Sponsor: University of Zurich

Brief Summary

The purpose of the current study is to evaluate the cerebral tissue oxygenation 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-23
• Study Start: 2017-05-24
• Study First Submitted QC: 2017-05-29
• Study First Posted: 2017-06-01
• Primary Completion: 2017-08-16
• Study Completion: 2017-08-16
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-15
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in cerebral tissue oxygenation	Year 2012 to 2017	Difference in the change in cerebral tissue oxygenation (CTO, measured by near infrared spectroscopy) 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

Secondary Outcome Measures

Name	Time	Method
Arterial oxygen saturation	Year 2012 to 2017	Difference in the change in the arterial oxygen saturation 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Changes in cerebrovascular response to hyperoxia	Year 2012 to 2017	Difference in the change in cerebrovascular response (total hemoglobin concentration, a surrogate to blood volume, measured by near infrared spectroscopy) to hyperoxia 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Changes in cerebrovascular response to hypocapnia	Year 2012 to 2017	Difference in the change in cerebrovascular response (total hemoglobin concentration, a surrogate to blood volume, measured by near infrared spectroscopy) to hypocapnia 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

Trial Locations

Locations (1)

National Center for Cardiology and Internal Medicine; 🇰🇬 Bishkek, Kyrgyzstan