Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02092675

Enrollment

117

Registered

2014-03-20

Start date

2013-03-31

Completion date

2014-05-31

Last updated

2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Endothelial Dysfunction

Keywords

Chronic obstructive pulmonary disease, frequent exacerbator, endothelial dysfunction, Flow mediated dilatation, Systemic inflammation

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
difference in endothelial dysfunction	6 months	Evidence of difference in endothelial dysfunction between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group

Secondary

Measure	Time frame	Description
difference in pulmonary functional tests	6 months	Difference in pulmonary functional test between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group

Other

Measure	Time frame	Description
difference in systemic inflammation	6 months	Difference in systemic inflammation between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group

Countries

Croatia

Outcome results