COPDNCT02721693
Troponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise
A study testing Treadmill exercise test in people with COPD and Myocardial Diseases, run by LHL Helse at 1 site in Norway.
Trial summary
The primary purpose of the study is to investigate if physical exercise is associated with myocardial damage, expressed by elevated troponin T, in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Myocardial Diseases
- What is being tested?
- Treadmill exercise test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2016to Oct 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD
- GOLD 2-4
- BODE-index ≥ 2
- Referred by physician to a CPET
Who cannot join
- Other serious pulmonary diseases (e.g. cancer, sarcoidosis, restrictive pulmonary diseases)
- Chronic heart disease with unstable angina or myocardial infarction ≤ 3 months prior to inclusion
- Percutaneous coronary intervention (PCI)
- Hypertension that is not controlled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COPD, Physical Exercise and Troponin T
The primary purpose of the study is to investigate if physical exercise is associated with myocardial damage, expressed by elevated troponin T, in patients with COPD.
Read the detailed description
Patients with COPD will perform a cardiopulmonary exercise test (CPET) on treadmill until exhaustion, 8-12 minutes. Venous blood will be drawn before exercise test and 15 minutes, 3 hours and 24 hours after test for analysis of high sensitive Cardiac troponin T (hs-cTnT). The investigators will also measure arterial bloodgas, oxygen uptake, carbon dioxide consumption, ventilation, blood pressure, ECG, heart rate and ask for dyspnea-score.
- Conditions
- COPD, Myocardial Diseases
- Being tested
- Treadmill exercise test
- Keywords
- Troponin, Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiomyopathies, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill exercise testDevice
Patients are subjected to an incremental exercise test to exhaustion on a treadmill
| Study group | Role | What they receive |
|---|---|---|
| Treadmill exercise test | Experimental | Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion Receives: Device: Treadmill exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin T concentration 3 h
Measured: 3 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Helene Edvardsen, LHL Helse
- Investigators
- Anne H Edvardsen, PhD, Principal investigator, LHL Helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721693
- Sponsor's protocol ID
- 2016/23140
- Other IDs
- 2016
- Status last verified
- Oct 2016
- First submitted
- 23 Mar 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD, Physical Exercise and Troponin T
- ClinicalTrials.gov ID
- NCT02721693
- Acronym / sponsor ID
- 2016/23140
- Conditions
- COPD, Myocardial Diseases
- Keywords
- Troponin, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Mar 2016 (estimated)
- 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.
The primary purpose of the study is to investigate if physical exercise is associated with myocardial damage, expressed by elevated troponin T, in patients with COPD.
Detailed description
Patients with COPD will perform a cardiopulmonary exercise test (CPET) on treadmill until exhaustion, 8-12 minutes. Venous blood will be drawn before exercise test and 15 minutes, 3 hours and 24 hours after test for analysis of high sensitive Cardiac troponin T (hs-cTnT). The investigators will also measure arterial bloodgas, oxygen uptake, carbon dioxide consumption, ventilation, blood pressure, ECG, heart rate and ask for dyspnea-score.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treadmill exercise test | Experimental | Device: Treadmill exercise testPatients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD
- GOLD 2-4
- BODE-index ≥ 2
- Referred by physician to a CPET
Key exclusion criteria (4 listed)
- Other serious pulmonary diseases (e.g. cancer, sarcoidosis, restrictive pulmonary diseases)
- Chronic heart disease with unstable angina or myocardial infarction ≤ 3 months prior to inclusion
- Percutaneous coronary intervention (PCI)
- Hypertension that is not controlled
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 |
|---|---|---|
| Treadmill exercise testPatients are subjected to an incremental exercise test to exhaustion on a treadmill | Device | Treadmill exercise test |
Primary outcome
Troponin T concentration 3 h
Time frame: 3 h
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 11 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Anne H Edvardsen, PhD principal investigator
LHL Helse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill exercise test in people with COPD and Myocardial Diseases, run by LHL Helse at 1 site in Norway.
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 4 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 11 Oct 2016. 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 Norway. 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?
Troponin T concentration 3 h (time frame: 3 h). 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 Oct 2016.