Autonomic Function in COPD and Risk for Atrial Fibrillation

November 7, 2019 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Characterization of Autonomic Function in Patients With Chronic Obstructive Pulmonary Disease - Potential Relevance for Increased Risk of Atrial Fibrillation

In the presented study, autonomic function as well as risk for atrial fibrillation will be assessed to characterize the relation between risk of atrial fibrillation and autonomic function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation (AF) has been suggested as relevant comorbidity in patients with chronic obstructive pulmonary disease (COPD). The evaluation of the total atrial conduction time via tissue Doppler imaging (PA-TDI interval) can be used to identify patients with increased risk of new onset AF. Autonomic function can be assessed by different non invasive clinical investigations.

The investigators hypothesise that PA-TDI interval is increased in acutely exacerbated COPD (AECOPD) compared within stable COPD and that increased PA-TDI is related to impairment of autonomic function. For this purpose, 25 patients with AECOPD and 25 patients with stable COPD were characterized by clinical characteristics, laboratory tests, lung function, electrocardiography, echocardiography and autonomic function.

Study Type

Observational

Enrollment (Actual)

50

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

  • Germany
      • Düsseldorf, Germany, 40225
        • University Hospital Düsseldorf, Division of Cardiology, Pulmonary Disease and Vascular Medicine

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic obstructive pulmonary disease, exacerbated or stable

Description

Inclusion Criteria:

  • patients with chronic obstructive pulmonary disease, exacerbated or stable between the age of 40-80 years with sinus rhythm who gave informed written consent

Exclusion Criteria:

  • Inability to give written consent, acute myocardial infarction with ST-segment elevations in last 30 days, severe acute or chronic renal dysfunction, severe heart failure, atrial fibrillation, severe valve disease, severe hypotension, active malignant disease, active rheumatic disease

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AECOPD
acute exacerbation of COPD
Other: Measurement of lung function, electrocardiography, echocardiography and autonomic function
Measurement of lung function, electrocardiography, echocardiography and autonomic function
stable COPD
Other: Measurement of lung function, electrocardiography, echocardiography and autonomic function
Measurement of lung function, electrocardiography, echocardiography and autonomic function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total atrial conduction time
Time Frame: Baseline
total atrial conduction time via tissue Doppler imaging (PA-TDI interval)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: Baseline
For the assessment of autonomic function different test that characterize sympathetic or parasympathic function are performed. All tests for autonomic function are non invasive.
Baseline
Baroreflex sensitivity
Time Frame: Baseline
For the assessment of autonomic function different test that characterize sympathetic or parasympathic function are performed. All tests for autonomic function are non invasive.
Baseline
Chemoreflex sensitivity
Time Frame: Baseline
For the assessment of autonomic function different test that characterize sympathetic or parasympathic function are performed. All tests for autonomic function are non invasive.
Baseline
Deep breathing test
Time Frame: Baseline
For the assessment of autonomic function different test that characterize sympathetic or parasympathic function are performed. All tests for autonomic function are non invasive.
Baseline
Ewing test
Time Frame: Baseline
For the assessment of autonomic function different test that characterize sympathetic or parasympathic function are performed. All tests for autonomic function are non invasive.
Baseline
Cold pressure test
Time Frame: Baseline
For the assessment of autonomic function different test that characterize sympathetic or parasympathic function are performed. All tests for autonomic function are non invasive.
Baseline
Cold face test
Time Frame: Baseline
For the assessment of autonomic function different test that characterize sympathetic or parasympathic function are performed. All tests for autonomic function are non invasive.
Baseline

Collaborators and Investigators

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

Sponsor

Heinrich-Heine University, Duesseldorf

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 (Actual)

March 1, 2019

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

November 8, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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