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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02092675
Other study ID # ED-1971-HR
Secondary ID ED-1971-UHCZ
Status Completed
Phase N/A
First received March 17, 2014
Last updated December 22, 2014
Start date March 2013
Est. completion date May 2014

Study information

Verified date December 2014
Source Clinical Hospital Centre Zagreb
Contact n/a
Is FDA regulated No
Health authority Croatia: Ethics Committee
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 85 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Croatia Univerity Hospital Centre Zagreb Zagreb

Sponsors (1)

Lead Sponsor Collaborator
Andrea Vukic Dugac

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Other difference in systemic inflammation Difference in systemic inflammation between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group 6 months Yes
Primary difference in endothelial dysfunction Evidence of difference in endothelial dysfunction between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group 6 months Yes
Secondary difference in pulmonary functional tests Difference in pulmonary functional test between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group 6 months Yes
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