Chronic Obstructive Pulmonary DiseaseNT-proBNPNCT01801722
Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Chronic Heart Failure, run by Lund University at 1 site in Sweden.
Trial summary
The aim of the present study was to evaluate if the analysis of NT-proBNP might be used as an initial step for the diagnosis of chronic heart failure in patients with COPD in primary health care, and to select patients for a further examination by echocardiography. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Heart Failure
- How many people
- 75 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2008to Jun 2008
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years and older with a registered diagnosis of COPD.
Who may be able to join
- Patients aged 65 years and older with the following diagnosis codes according to International Statistical Classification of Diseases and Related Health Problems - Tenth Revision:J44 (COPD) and J41, J42 (chronic bronchitis) registered during the period 1 January 2008-16 April 2008 according to the electronic patient record.
Who cannot join
- Impaired cognitive function and/or anticipated difficulties in carrying out spirometry due to immobility,
- psychiatric disorders or terminal illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease.
The aim of the present study was to evaluate if the analysis of NT-proBNP might be used as an initial step for the diagnosis of chronic heart failure in patients with COPD in primary health care, and to select patients for a further examination by echocardiography.
Read the detailed description
Patients with a confirmed diagnosis of COPD were examined regarding chronic heart failure.
- An interview regarding symptoms: breathlessness, orthopnoea, night cough, nocturia, walking distance.
- Physical examination: weight and height, heart and lung auscultation, blood pressure measurement after 5 minutes' rest in the sitting position and the presence of peripheral oedema.
- Electrocardiography.
- Natriuretic peptide- NT-proBNP (Immulite 2500, Siemens Healthcare Diagnostics AB Sweden).
- Patients with the NT-proBNP level of > 1200 pg/ml were referred for echocardiography to assess left ventricular function.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| NT-proBNP,ejection fraction ,COPD stage. | The group comprised 25 women (47%) and 28 men (53%). The mean age was 75.4 years (SD 7.9), 76.3 (SD 7.6) for men and 74.4 (SD 8.2) for women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with elevated NT-proBNP.
NT-proBNP has taken only once in each patient without follow up follow up. Three months was a period when we collected data from all participants.
Measured: 3 months
Secondary outcomes (1)
Percentage of patients with abnormal left ventricular function assessed by echocardiography. Association between elevated NT-proBNP and symptoms, signs and electrocardiography.
Echocardiography was performed once in each referred patient. Three months was a period of data collection.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 2008
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.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzbieta Kaszuba, Lund University
- Investigators
- Elzbieta Kaszuba, PhD student, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801722
- Sponsor's protocol ID
- 502008
- Other IDs
- DN50/2008
- Acronym
- NT-proBNP
- Status last verified
- Mar 2018
- First submitted
- 25 Feb 2013
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT01801722
- Acronym / sponsor ID
- NT-proBNP / 502008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Mar 2013 (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 aim of the present study was to evaluate if the analysis of NT-proBNP might be used as an initial step for the diagnosis of chronic heart failure in patients with COPD in primary health care, and to select patients for a further examination by echocardiography.
Detailed description
Patients with a confirmed diagnosis of COPD were examined regarding chronic heart failure.
- An interview regarding symptoms: breathlessness, orthopnoea, night cough, nocturia, walking distance.
- Physical examination: weight and height, heart and lung auscultation, blood pressure measurement after 5 minutes' rest in the sitting position and the presence of peripheral oedema.
- Electrocardiography.
- Natriuretic peptide- NT-proBNP (Immulite 2500, Siemens Healthcare Diagnostics AB Sweden).
- Patients with the NT-proBNP level of > 1200 pg/ml were referred for echocardiography to assess left ventricular function.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NT-proBNP,ejection fraction ,COPD stage. | – | –The group comprised 25 women (47%) and 28 men (53%). The mean age was 75.4 years (SD 7.9), 76.3 (SD 7.6) for men and 74.4 (SD 8.2) for women. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years and older with a registered diagnosis of COPD.
Key inclusion criteria (1 listed)
- Patients aged 65 years and older with the following diagnosis codes according to International Statistical Classification of Diseases and Related Health Problems - Tenth Revision:J44 (COPD) and J41, J42 (chronic bronchitis) registered during the period 1 January 2008-16 April 2008 according to the electronic patient record.
Key exclusion criteria (2 listed)
- Impaired cognitive function and/or anticipated difficulties in carrying out spirometry due to immobility,
- psychiatric disorders or terminal illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with elevated NT-proBNP.
Time frame: 3 months
NT-proBNP has taken only once in each patient without follow up follow up. Three months was a period when we collected data from all participants.
1 secondary outcome
Percentage of patients with abnormal left ventricular function assessed by echocardiography. Association between elevated NT-proBNP and symptoms, signs and electrocardiography.
Time frame: 3 months
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 7 Mar 2018.
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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.
Elzbieta Kaszuba, PhD student principal investigator
Lund University
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 and Chronic Heart Failure, run by Lund University at 1 site in Sweden.
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 2 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 7 Mar 2018. 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 Sweden. 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?
Percentage of patients with elevated NT-proBNP. (time frame: 3 months). 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 7 Mar 2018.