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NCT Number: NCT03165019

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

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.

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Key information

Conditions

High Altitude Pulmonary Hypertension Apnea Cardiovascular Diseases Disease Attributes Disease Progression Dyssomnias Hypertension Hypertension, Pulmonary Hypoxia Lung Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary edema of mountaineers Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders 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

Healthy volunteers accepted: Yes

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 pulmonary artery pressure

    Time frame: Year 2012 to 2017

    Difference 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 outcomes

  1. Changes in nocturnal arterial oxygen saturation

    Time frame: Year 2012 to 2017

    Difference in the change in the nocturnal arterial oxygen saturation 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

  2. Survival

    Time frame: Year 2012 to 2017

    Cumulative incidence of death and relocation to lower altitudes between 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

  3. Progression of oxygen desaturation index

    Time frame: Year 2012 to 2017

    Difference in the change in the oxygen desaturation index 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

  4. Progression of quality of life

    Time frame: Year 2012 to 2017

    Difference 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

  5. Progression of cognitive performance

    Time frame: Year 2012 to 2017

    Difference in the change in the mean reaction time 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

  6. Exercise performance

    Time frame: Year 2012 to 2017

    Difference in the change in 6 minute walk distance 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

  7. Arterial blood gas analysis

    Time frame: Year 2012 to 2017

    Difference in the change in arterial blood gases 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 24, 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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