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Completed

NCT Number: NCT03871933

Autonomic Function in COPD and Risk for 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Chronic Disease Disease Attributes Heart Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Düsseldorf, 40225, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of lung function, electrocardiography, echocardiography and autonomic function

Other

Measurement of lung function, electrocardiography, echocardiography and autonomic function

Primary outcomes

  1. total atrial conduction time

    Time frame: Baseline

    total atrial conduction time via tissue Doppler imaging (PA-TDI interval)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2019
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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