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Right Ventricular Function at Rest in Highlanders/Lowlanders

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ClinicalTrials.gov Identifier: NCT03165656
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Information provided by (Responsible Party):
Silvia Ulrich Somaini, University of Zurich

Brief Summary:
The purpose of the current study is to evaluate the progression of right ventricular function and dimension in Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a cross sectional case-control study.

Condition or disease
High Altitude Pulmonary Hypertension

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Study Type : Observational [Patient Registry]
Actual Enrollment : 173 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: Right Ventricular Function at Rest in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : August 16, 2017
Actual Study Completion Date : August 16, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Pulmonary artery pressure [ Time Frame: Day 2 ]
    Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in tricuspid pressure gradient, measured by transthoracic echocardiography


Secondary Outcome Measures :
  1. cardiac output [ Time Frame: Day 2 ]
    Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in cardiac output, measured by transthoracic echocardiography

  2. right heart dimensions [ Time Frame: Day 2 ]
    Difference of right heart dimensions between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography

  3. Right heart function [ Time Frame: Day 2 ]
    Differences of right heart function between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography (TAPSE)

  4. stroke volume [ Time Frame: Day 2 ]
    Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in stroke volume, measured by transthoracic echocardiography

  5. volumes [ Time Frame: Day 2 ]
    Difference of volumes between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Highlanders with high altitude pulmonary 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165656


Locations
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Kyrgyzstan
National Center for Cardiology and Internal Medicine
Bishkek, Kyrgyzstan, 720040
Sponsors and Collaborators
University of Zurich
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Investigators
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Study Chair: Talant M Sooronbaev, MD National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Silvia Ulrich Somaini, Prof. Dr., University of Zurich
ClinicalTrials.gov Identifier: NCT03165656    
Other Study ID Numbers: 01-8/433A
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silvia Ulrich Somaini, University of Zurich:
Echocardiography
right ventricular function
pulmonary hypertension
disease progression
hypoxia
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases