Chronic Obstructive Pulmonary DiseaseNCT03871933
Autonomic Function in COPD and Risk for Atrial Fibrillation
An observational study of Chronic Obstructive Pulmonary Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Measurement of lung function, electrocardiography, echocardiography and autonomic function
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2019to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with chronic obstructive pulmonary disease, exacerbated or stable
Who may be able to join
- patients with chronic obstructive pulmonary disease, exacerbated or stable between the age of 40-80 years with sinus rhythm who gave informed written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Düsseldorf, Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Measurement of lung function, electrocardiography, echocardiography and autonomic function
- Keywords
- atrial fibrillation, autonomic function, cardiopulmonary interaction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of lung function, electrocardiography, echocardiography and autonomic functionOther
Measurement of lung function, electrocardiography, echocardiography and autonomic function
| Study group | Role | What they receive |
|---|---|---|
| AECOPD | acute exacerbation of COPD Receives: Other: Measurement of lung function, electrocardiography, echocardiography and autonomic function | |
| stable COPD | Not described Receives: Other: Measurement of lung function, electrocardiography, echocardiography and autonomic function |
What is being measured
The primary outcome is the main question the study is designed to answer.
total atrial conduction time
total atrial conduction time via tissue Doppler imaging (PA-TDI interval)
Measured: Baseline
Secondary outcomes (7)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Mar 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871933
- Sponsor's protocol ID
- 16-029
- Status last verified
- Nov 2019
- First submitted
- 11 Mar 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Autonomic Function in Patients With Chronic Obstructive Pulmonary Disease - Potential Relevance for Increased Risk of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03871933
- Acronym / sponsor ID
- 16-029
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- atrial fibrillation, autonomic function, cardiopulmonary interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AECOPD | – | Other: Measurement of lung function, electrocardiography, echocardiography and autonomic functionacute exacerbation of COPD |
| stable COPD | – | Other: Measurement of lung function, electrocardiography, echocardiography and autonomic function |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic obstructive pulmonary disease, exacerbated or stable
Key inclusion criteria (1 listed)
- patients with chronic obstructive pulmonary disease, exacerbated or stable between the age of 40-80 years with sinus rhythm who gave informed written consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of lung function, electrocardiography, echocardiography and autonomic functionMeasurement of lung function, electrocardiography, echocardiography and autonomic function | Other | AECOPD, stable COPD |
Primary outcome
total atrial conduction time
Time frame: Baseline
total atrial conduction time via tissue Doppler imaging (PA-TDI interval)
7 secondary outcomes
Heart rate variability
Time frame: Baseline
Baroreflex sensitivity
Time frame: Baseline
Chemoreflex sensitivity
Time frame: Baseline
Deep breathing test
Time frame: Baseline
Ewing test
Time frame: Baseline
Cold pressure test
Time frame: Baseline
Cold face test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total atrial conduction time (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.