Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

December 22, 2014 updated by: Andrea Vukic Dugac

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Univerity Hospital Centre Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with COPD, smokers and former smokers recruited in an ambulatory basis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in endothelial dysfunction
Time Frame: 6 months
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
Time Frame: 6 months
Difference in pulmonary functional test between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in systemic inflammation
Time Frame: 6 months
Difference in systemic inflammation between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrea Vukic Dugac

Investigators

  • Principal Investigator: Andrea Vukic Dugac, University Hospital Zagreb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (ESTIMATE)

March 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED-1971-HR
  • ED-1971-UHCZ (OTHER: University Hospital Centre Zagreb)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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