Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

Overview

The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.

Full Title of Study: “Endothelial Dysfunction and Frequent Exacerbator Phenotype in Patient With Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2014

Detailed Description

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in developed countries. Acute exacerbations and cardiovascular diseases are the major causes of morbidity and mortality in COPD patients. According to the frequency of exacerbations, phenotype "frequent exacerbator" is defined and characterised with severe clinical course and was recognised as an increased risk for cardiovascular mortality. Recent studies considered that systemic inflammation plays a key role in the pathogenesis of COPD and endothelial dysfunction is a suspected link between increased cardiovascular mortality and systemic inflammation in COPD patients. Endothelial dysfunction is assessed by determining flow mediated dilatation index (FMD index) or plasma markers. Previous studies have suggested the presence of endothelial dysfunction in COPD patients, as well as the deterioration of endothelial function during exacerbations of COPD. This study will, for the first time, systematically explore endothelial dysfunction in two phenotypically distinct groups of COPD patients with simultaneous assessment of endothelial function flow mediated dilatation index (FMD index) and plasma markers.

Arms, Groups and Cohorts

  • COPD patients – frequent exacerbator
    • COPD patients with 2 and more exacerbation in one year
  • COPD patients – non frequent exacerbator
    • COPD patients with less than 2 exacerbation during one year
  • control group – healthy smokers
    • healthy smokers, they do not have COPD

Clinical Trial Outcome Measures

Primary Measures

  • difference in endothelial dysfunction
    • Time Frame: 6 months
    • Evidence of difference in endothelial dysfunction between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group

Secondary Measures

  • difference in pulmonary functional tests
    • Time Frame: 6 months
    • Difference in pulmonary functional test between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group

Participating in This Clinical Trial

Inclusion Criteria

  • COPD patients in stable condition ( without exacerbation min 1 months ago)
  • Over 40 years
  • History of at least 10 py

Exclusion Criteria

  • acute exacerbation of COPD
  • active malignancy
  • autoimmune disease
  • acute myocardial infarction
  • diabetes mellitus with late complications
  • congestive heart failure
  • women of childbearing potential

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Andrea Vukic Dugac
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Andrea Vukic Dugac, pulmonary disease specialist – Clinical Hospital Centre Zagreb
  • Overall Official(s)
    • Andrea Vukic Dugac, Principal Investigator, University Hospital Zagreb

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