Cerebral Tissue Oxygenation in Highlanders/Lowlanders

NCT03172429 | Completed

• 1 other identifier: 01-8/433C
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

High Altitude Pulmonary Hypertension

Keywords

pulmonary hypertension; cerebral tissue oxygenation; disease progression; hypoxia

Outcome Measures

Primary Outcomes (1)

• Changes in cerebral tissue oxygenation

  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

  Year 2012 to 2017

Secondary Outcomes (3)

• Changes in cerebrovascular response to hyperoxia

  Year 2012 to 2017

• Changes in cerebrovascular response to hypocapnia

  Year 2012 to 2017

• Arterial oxygen saturation

  Year 2012 to 2017

Study Arms (3)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator

Study Sites (1)

National Center for Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

MeSH Terms

Conditions

Pulmonary edema of mountaineers; Hypertension, Pulmonary; Disease Progression; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Talant M Sooronbaev, MD

  NCCIM

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 1, 2017
• Study Start: May 24, 2017
• Primary Completion: August 16, 2017
• Study Completion: August 16, 2017
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

KY (1)