Cerebral Tissue Oxygenation in Highlanders/Lowlanders

Cerebral Tissue Oxygenation in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03172429

Enrollment

Registered

2017-06-01

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

Keywords

pulmonary hypertension, cerebral tissue oxygenation, disease progression, hypoxia

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

Kyrgyzstan

Outcome results