Autonomic Function in COPD and Risk for Atrial Fibrillation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871933
• Other study ID #: 16-029
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: November 2019
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Measurement of lung function, electrocardiography, echocardiography and autonomic function
Measurement of lung function, electrocardiography, echocardiography and autonomic function

Locations

Country	Name	City	State
Germany	University Hospital Düsseldorf, Division of Cardiology, Pulmonary Disease and Vascular Medicine	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total atrial conduction time	total atrial conduction time via tissue Doppler imaging (PA-TDI interval)	Baseline
Secondary	Heart rate variability	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
Secondary	Baroreflex sensitivity	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
Secondary	Chemoreflex sensitivity	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
Secondary	Deep breathing test	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
Secondary	Ewing test	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
Secondary	Cold pressure test	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
Secondary	Cold face test	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