Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

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

• Chronic Obstructive Pulmonary Disease
• Endothelial Dysfunction
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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