Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

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

Detailed Description
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease, Endothelial Dysfunction

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD patients - frequent exacerbator<br>COPD patients with 2 and more exacerbation in one year | |
| COPD patients - non frequent exacerbator<br>COPD patients with less than 2 exacerbation during one year | |
| control group - healthy smokers<br>healthy smokers, they do not have COPD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, frequent exacerbator, endothelial dysfunction, Flow mediated dilatation, Systemic inflammation