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Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02092675
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Andrea Vukic Dugac, Clinical Hospital Centre Zagreb

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

Condition or disease
Chronic Obstructive Pulmonary Disease Endothelial Dysfunction

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.

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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Endothelial Dysfunction and Frequent Exacerbator Phenotype in Patient With Chronic Obstructive Pulmonary Disease
Study Start Date : March 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Other Outcome Measures:
  1. difference in systemic inflammation [ Time Frame: 6 months ]
    Difference in systemic inflammation between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group


Biospecimen Retention:   Samples Without DNA
plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patient with COPD, smokers and former smokers recruited in an ambulatory basis.
Criteria

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

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): NCT02092675


Locations
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Croatia
Univerity Hospital Centre Zagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
Andrea Vukic Dugac
Investigators
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Principal Investigator: Andrea Vukic Dugac University Hospital Zagreb
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Responsible Party: Andrea Vukic Dugac, pulmonary disease specialist, Clinical Hospital Centre Zagreb
ClinicalTrials.gov Identifier: NCT02092675    
Other Study ID Numbers: ED-1971-HR
ED-1971-UHCZ ( Other Identifier: University Hospital Centre Zagreb )
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014
Keywords provided by Andrea Vukic Dugac, Clinical Hospital Centre Zagreb:
Chronic obstructive pulmonary disease
frequent exacerbator
endothelial dysfunction
Flow mediated dilatation
Systemic inflammation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases