Chronic Obstructive Pulmonary DiseaseNCT03889964
Exercise Capacity in COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
In this study, cardiopulmonary exercise will be assessed to characterize the relevance of severity of COPD and coexisting cardiovascular comorbidities for exercise capacity. Read more about this study
- Who is it for?
- Ages 40 to 40 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2019to Dec 2020
- 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 40 years
- All sexes
- Adult
Study population: Patients with stabile chronic obstructive pulmonary disease
Who may be able to join
- patients with stable chronic obstructive pulmonary disease, exacerbated or stable
- 40-80 years
- sinus rhythm
- 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 hypoxemia
- long term oxygen therapy or non invasive ventilation
Trial locations and contacts
1 site in 1 country.
Rabea Wagstaff, M.A. contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Düsseldorf, Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
Stefanie Keymel, MD
Stefanie Keymel, MD
About this study
Official title: Reduced Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease -Relevance of Cardiovascular Comorbidities
In this study, cardiopulmonary exercise will be assessed to characterize the relevance of severity of COPD and coexisting cardiovascular comorbidities for exercise capacity.
Read the detailed description
In patients with chronic obstructive pulmonary disease (COPD) the interpretation of dyspnoea also needs to consider coexisting cardiovascular disease. Cardiopulmonary exercise testing (CPET) is used to characterize pulmonary and cardiac function and limitations during exercise. The investigators hypothesise that cardiopulmonary exercise is reduced in COPD patients with coexisting cardiovascular disease as well as in more symptomatic patients and in patients with frequent exacerbations. For this purpose, 100 patients with with stable COPD are characterized by clinical characteristics, laboratory tests, lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing
- Keywords
- cardiopulmonary exercise testing, cardiovascular comorbidities, cardiopulmonary interaction
- 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.
Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testingOther
Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing
| Study group | Role | What they receive |
|---|---|---|
| patients with stable COPD | Not described Receives: Other: Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
Measured: Baseline
Secondary outcomes (8)
measurement of dyspnoea quantified by the COPD assessment test as well as the modified Medical Research Council Scale
For the assessment of the symptoms of the study group and its relation to exercise capacity dyspnoea is assessed by accepted questionnaires typically used for COPD patients at baseline
Measured: Baseline
Measurement of FEV1
Measured: Baseline
Measurement the capillary pO2 in mmHg and capillary pCO2 at baseline
The blood gases pO2 and pCO2 are taken from the hyperaemic ear lobe to characterize the gas exchange during cardiopulmonary exercise which is a routine procedure
Measured: Baseline
N-terminal pro brain natriuretic peptid (NTproBNP) in ng/L from peripheral venous blood at baseline
NTproBNP is analysed from peripheral venous blood to characterize potential heart failure and its relation to exercise capacity of the study subjects
Measured: Baseline
Measurement of Maximum wattage during cardiopulmonary exercise testing
Measured: Baseline
Measurement of Breathing reserve during cardiopulmonary exercise testing
BThe breathing reserve in % is assessed at the end of the cardiopulmonary exercise testing to characterize a ventilatory limitation of the exercise test. It is calculated as percent from the minute ventilation in relation to the maximum mandatory ventilation. The measurement is a routine measurement during cardiopulmonary exercise testing.
Measured: Baseline
Measurement of Oxygen pulse during cardiopulmonary exercise testing
Measured: Baseline
Presence of cardiovascular comorbidities
For the cardiopulmonary characterization clinical characteristics, lung function, blood gases, laboratory investigation, ECG and echocardiography were used in addition to cardiopulmonary exercise testing.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Mar 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889964
- Sponsor's protocol ID
- 17-033
- Status last verified
- Feb 2020
- First submitted
- 11 Mar 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease -Relevance of Cardiovascular Comorbidities
- ClinicalTrials.gov ID
- NCT03889964
- Acronym / sponsor ID
- 17-033
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- cardiopulmonary exercise testing, cardiovascular comorbidities, cardiopulmonary interaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 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 this study, cardiopulmonary exercise will be assessed to characterize the relevance of severity of COPD and coexisting cardiovascular comorbidities for exercise capacity.
Detailed description
In patients with chronic obstructive pulmonary disease (COPD) the interpretation of dyspnoea also needs to consider coexisting cardiovascular disease. Cardiopulmonary exercise testing (CPET) is used to characterize pulmonary and cardiac function and limitations during exercise. The investigators hypothesise that cardiopulmonary exercise is reduced in COPD patients with coexisting cardiovascular disease as well as in more symptomatic patients and in patients with frequent exacerbations. For this purpose, 100 patients with with stable COPD are characterized by clinical characteristics, laboratory tests, lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with stable COPD | – | Other: Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing |
Who may qualify
- Ages
- 40 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with stabile chronic obstructive pulmonary disease
Key inclusion criteria (4 listed)
- patients with stable chronic obstructive pulmonary disease, exacerbated or stable
- 40-80 years
- sinus rhythm
- informed written consent
Key exclusion criteria (8 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
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 cardiopulmonary exercise testingMeasurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing | Other | patients with stable COPD |
Primary outcome
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
Time frame: Baseline
8 secondary outcomes
measurement of dyspnoea quantified by the COPD assessment test as well as the modified Medical Research Council Scale
Time frame: Baseline
Measurement of FEV1
Time frame: Baseline
Measurement the capillary pO2 in mmHg and capillary pCO2 at baseline
Time frame: Baseline
N-terminal pro brain natriuretic peptid (NTproBNP) in ng/L from peripheral venous blood at baseline
Time frame: Baseline
Measurement of Maximum wattage during cardiopulmonary exercise testing
Time frame: Baseline
Measurement of Breathing reserve during cardiopulmonary exercise testing
Time frame: Baseline
Measurement of Oxygen pulse during cardiopulmonary exercise testing
Time frame: Baseline
Presence of cardiovascular comorbidities
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Rabea Wagstaff, M.A. contact
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 Klinik für Kardiologie, Pneumologie und Angiologie 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Keymel, MD (+492118118800, ctsu@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted) (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 11 Feb 2020.