Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

Sponsor

Andrea Vukic Dugac (Other)

Overall Status

Completed

CT.gov ID

NCT02092675

Collaborator

(none)

117

Enrollment

Location

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

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 :

Mar 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

difference in systemic inflammation [6 months]
Difference in systemic inflammation between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group