Autonomic Function in Patients With Chronic Obstructive Pulmonary DiseaseNCT05667311
Autonomic Function in Patients With COPD
An observational study of Autonomic Function in Patients With Chronic Obstructive Pulmonary Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Conduct an in-depth evaluation of autonomic function using a validated tests, assess genetic aspects of autonomic failure, and determine the correlation between of autonomic function failure and other clinical variables in patients with COPD. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Autonomic Function in Patients With Chronic Obstructive Pulmonary Disease
- What is being tested?
- ECG
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2016to 31 Dec 2018
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD attending the respiratory medicine department or the pulmonary rehabilitation division of Ghent University Belgium.
Who may be able to join
- Stable COPD Ambulant
Who cannot join
- Recent hospitilization (3 months) Recent exacerbation (3 months) Other chronic systemic diseases (eg CHF, DM)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Autonomic Function Deficits in Patients With Chronic Obstructive Pulmonary Disease
Conduct an in-depth evaluation of autonomic function using a validated tests, assess genetic aspects of autonomic failure, and determine the correlation between of autonomic function failure and other clinical variables in patients with COPD.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a highly prevalent systemic disease that is caused by both environmental determinants and genetic risk factors. Patients with COPD also present with several comorbidities affecting their overall health status (Berndt et al, 2012). The investigators have demonstrated from recently conducted systematic reviews that patients with COPD have significant impairments in autonomic function (Mohammed et al, 2015). Our ongoing hospital survey (preliminary results) also indicates these patients have significant autonomic complaints (symptoms). Consequently, the objectives of this present study are to; i) conduct an in-depth evaluation of autonomic function using a validated battery of tests, (ii) assess genetic aspects of autonomic failure, and (iii) to determine the correlation between of autonomic function failure and other clinical variables in patients with COPD.
Based on the experience of our group (PhD- De Wandele, 2014), the investigators will evaluate the cardiovascular function (reflexes) in patients with COPD of different GOLD stages. The recruitment will be based on our recent questionnaire study. The patients will be evaluated by four validated tests. The first test is the HRV at rest. In this test, the ECG during 30 minutes will be registered while the patient lies supine. The R-R intervals analysis will be evaluated by time (mean and standard deviation (SD) and other derived parameters such as SDNN) and frequency (Fast Fourier analysis to measure high frequency, low frequency bands and the ratio of HF/LF) domain parameters. The second test is the deep breathing maneuver. This test will be based on the phenomenon of respiratory arrhythmia. Here, patients will be asked to breath in and out at an imposed rhythm (8 cycles of 5 seconds in and 5 seconds out) that will be displayed on a screen (laptop). For this test, changes of heart rate (ECG) at breathing in and breathing out will be analyzed to ascertain its impact on parasympathetic activity. The third test is the valsalva manoeuver (which is evoked by blowing into a tube at a pressure between 40 and 50 mmHg for 15 seconds/3 trials). During this test (ECG recordings), the valsalva ratio (parasympathetic measure) and the 4 phases of blood pressure response (sympathetic reactivity) will be calculated and quantified (Novak, 2011). The adrenergic, vagal and global baroreflex sensitivity parameters will also be calculated (Schrezenmaier et al. 2007) from the ECG recordings. The fourth and last test is the head up tilt test. Here, the patient after 5 minutes of rest in supine position will be tilted rapidly to 60°. Due to redistribution of the blood in the body, this test is normally expected to evoke changes in blood pressure and heart rate that will be compared with the baseline measures. The tilt test (position) will last about 20 minutes. The initial orthostatic (hypotension) status will be taken into account.
In the end, the investigators will calculate a "composite autonomic severity score" (CASS) based on cardiogenic and adrenegic functions thats will be derived from tests. the CASS results will range from 0 (no autonomic deficit) to 10 (maximal deficit). Also, the CASS score will be associated with different parameters. These include anthropometric measures (BMI, weight, height, fat free mass and fat mass), disease phenotyping (lung function (tiffeneau-index, breathing frequency, ventilatory effort, dyspnea, number of exacerbations, disease progression, anxiety and subjective well-being) and medication usage.
This study also has a genetic aspect that will be carried out concurrently. Here, the investigators aim to determine the prevalence of autonomic failure genes in these patients and also correlate same with autonomic performance. For this, venous blood samples will be collected by a a nurse. These samples will be relayed to the medical genetics Department for DNA extraction and evaluation (polymorphisms). The evaluation will be based upon identification of autonomic failure genes that were earlier reported by Mathias \& Bannister ( 2013). These genes include α2b-adrenergic receptor (5ADRA2B), dopamine receptor D4, Solute carrier family 6 (neurotransmitter transporter noradrenaline)-member 2, ........ This part of the study will be done in collaboration with the Medical Genetics Centre of the University Hospital Ghent.
In total, the investigators are aiming to recruit 50 patients.
- Being tested
- ECG
- Keywords
- Genetics, COPD, Autonomic nervous system
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDevice
Finapres electrocardiography machine
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic symptom score (COMPASS 31) questionnaire
Asses orthostatic intolerance
Measured: 1 hour
Autonomic symptom score (COMPASS 31) questionnaire
Asses autonomic symptoms
Measured: 1 hour
Autonomic symptom score (COMPASS 31) questionnaire
Asses secretomotor symptoms
Measured: 1 hour
Autonomic symptom score (COMPASS 31) questionnaire
Asses gastrointestinal symptoms
Measured: 1 hour
Autonomic symptom score (COMPASS 31) questionnaire
Asses urinary symptoms
Measured: 1 hour
Autonomic symptom score (COMPASS 31) questionnaire
Asses pupillomotor symptoms
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study startJul 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Function in Patients With 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
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Joos, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667311
- Sponsor's protocol ID
- B670201628572
- Status last verified
- Dec 2022
- First submitted
- 16 Aug 2016
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autonomic Function Deficits in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05667311
- Acronym / sponsor ID
- B670201628572
- Keywords
- Genetics, COPD, Autonomic nervous system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Dec 2022 (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.
Conduct an in-depth evaluation of autonomic function using a validated tests, assess genetic aspects of autonomic failure, and determine the correlation between of autonomic function failure and other clinical variables in patients with COPD.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a highly prevalent systemic disease that is caused by both environmental determinants and genetic risk factors. Patients with COPD also present with several comorbidities affecting their overall health status (Berndt et al, 2012). The investigators have demonstrated from recently conducted systematic reviews that patients with COPD have significant impairments in autonomic function (Mohammed et al, 2015). Our ongoing hospital survey (preliminary results) also indicates these patients have significant autonomic complaints (symptoms). Consequently, the objectives of this present study are to; i) conduct an in-depth evaluation of autonomic function using a validated battery of tests, (ii) assess genetic aspects of autonomic failure, and (iii) to determine the correlation between of autonomic function failure and other clinical variables in patients with COPD.
Based on the experience of our group (PhD- De Wandele, 2014), the investigators will evaluate the cardiovascular function (reflexes) in patients with COPD of different GOLD stages. The recruitment will be based on our recent questionnaire study. The patients will be evaluated by four validated tests. The first test is the HRV at rest. In this test, the ECG during 30 minutes will be registered while the patient lies supine. The R-R intervals analysis will be evaluated by time (mean and standard deviation (SD) and other derived parameters such as SDNN) and frequency (Fast Fourier analysis to measure high frequency, low frequency bands and the ratio of HF/LF) domain parameters. The second test is the deep breathing maneuver. This test will be based on the phenomenon of respiratory arrhythmia. Here, patients will be asked to breath in and out at an imposed rhythm (8 cycles of 5 seconds in and 5 seconds out) that will be displayed on a screen (laptop). For this test, changes of heart rate (ECG) at breathing in and breathing out will be analyzed to ascertain its impact on parasympathetic activity. The third test is the valsalva manoeuver (which is evoked by blowing into a tube at a pressure between 40 and 50 mmHg for 15 seconds/3 trials). During this test (ECG recordings), the valsalva ratio (parasympathetic measure) and the 4 phases of blood pressure response (sympathetic reactivity) will be calculated and quantified (Novak, 2011). The adrenergic, vagal and global baroreflex sensitivity parameters will also be calculated (Schrezenmaier et al. 2007) from the ECG recordings. The fourth and last test is the head up tilt test. Here, the patient after 5 minutes of rest in supine position will be tilted rapidly to 60°. Due to redistribution of the blood in the body, this test is normally expected to evoke changes in blood pressure and heart rate that will be compared with the baseline measures. The tilt test (position) will last about 20 minutes. The initial orthostatic (hypotension) status will be taken into account.
In the end, the investigators will calculate a "composite autonomic severity score" (CASS) based on cardiogenic and adrenegic functions thats will be derived from tests. the CASS results will range from 0 (no autonomic deficit) to 10 (maximal deficit). Also, the CASS score will be associated with different parameters. These include anthropometric measures (BMI, weight, height, fat free mass and fat mass), disease phenotyping (lung function (tiffeneau-index, breathing frequency, ventilatory effort, dyspnea, number of exacerbations, disease progression, anxiety and subjective well-being) and medication usage.
This study also has a genetic aspect that will be carried out concurrently. Here, the investigators aim to determine the prevalence of autonomic failure genes in these patients and also correlate same with autonomic performance. For this, venous blood samples will be collected by a a nurse. These samples will be relayed to the medical genetics Department for DNA extraction and evaluation (polymorphisms). The evaluation will be based upon identification of autonomic failure genes that were earlier reported by Mathias \& Bannister ( 2013). These genes include α2b-adrenergic receptor (5ADRA2B), dopamine receptor D4, Solute carrier family 6 (neurotransmitter transporter noradrenaline)-member 2, ........ This part of the study will be done in collaboration with the Medical Genetics Centre of the University Hospital Ghent.
In total, the investigators are aiming to recruit 50 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD attending the respiratory medicine department or the pulmonary rehabilitation division of Ghent University Belgium.
Key inclusion criteria (1 listed)
- Stable COPD Ambulant
Key exclusion criteria (1 listed)
- Recent hospitilization (3 months) Recent exacerbation (3 months) Other chronic systemic diseases (eg CHF, DM)
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 |
|---|---|---|
| ECGFinapres electrocardiography machine | Device | – |
Primary outcome
Autonomic symptom score (COMPASS 31) questionnaire
Time frame: 1 hour
Asses orthostatic intolerance
Autonomic symptom score (COMPASS 31) questionnaire
Time frame: 1 hour
Asses autonomic symptoms
Autonomic symptom score (COMPASS 31) questionnaire
Time frame: 1 hour
Asses secretomotor symptoms
Autonomic symptom score (COMPASS 31) questionnaire
Time frame: 1 hour
Asses gastrointestinal symptoms
Autonomic symptom score (COMPASS 31) questionnaire
Time frame: 1 hour
Asses urinary symptoms
Autonomic symptom score (COMPASS 31) questionnaire
Time frame: 1 hour
Asses pupillomotor symptoms
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 28 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Autonomic Function in Patients With Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease Moderate, Chronic Obstructive Pulmonary Disease Severe
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 Autonomic Function in Patients With Chronic Obstructive Pulmonary Disease, run by University Hospital, Ghent at 1 site in Belgium.
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 28 Dec 2022. 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 Belgium. 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?
Autonomic symptom score (COMPASS 31) questionnaire (time frame: 1 hour). The study lists 6 primary outcomes in all. 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 28 Dec 2022.