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Completed

NCT Number: NCT02092675

Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

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

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Univerity Hospital Centre Zagreb

Zagreb, Croatia, 10000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Andrea Vukic Dugac

Other

Registry information

Official study title

Endothelial Dysfunction and Frequent Exacerbator Phenotype in Patient With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 20, 2014
Registry last updated
Dec 24, 2014

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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