Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

Completed

• Conditions: Endothelial Dysfunction; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT02092675
• Lead Sponsor: Andrea Vukic Dugac

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-20
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-22
• Last Update Posted: 2014-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Univerity Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia