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NCT Number: NCT03172429

Cerebral Tissue Oxygenation in Highlanders/Lowlanders

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.

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Key information

Conditions

High Altitude Pulmonary Hypertension Cardiovascular Diseases Disease Attributes Disease Progression Hypertension Hypertension, Pulmonary Hypoxia Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary edema of mountaineers Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes in cerebral tissue oxygenation

    Time frame: 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 outcomes

  1. Changes in cerebrovascular response to hyperoxia

    Time frame: 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

  2. Changes in cerebrovascular response to hypocapnia

    Time frame: 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

  3. Arterial oxygen saturation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2017
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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