- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01801722
Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease (NT-proBNP)
March 6, 2018 updated by: Elzbieta Kaszuba, Lund University
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Blekinge
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Olofström, Blekinge, Sweden, 29332
- Primary health care center.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients aged 65 years and older with a registered diagnosis of COPD.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Impaired cognitive function and/or anticipated difficulties in carrying out spirometry due to immobility,
- psychiatric disorders or terminal illness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of patients with elevated NT-proBNP.
Time Frame: 3 months
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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.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Echocardiography was performed once in each referred patient.
Three months was a period of data collection.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elzbieta Kaszuba, PhD student, Lund University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
February 25, 2013
First Submitted That Met QC Criteria
February 28, 2013
First Posted (Estimate)
March 1, 2013
Study Record Updates
Last Update Posted (Actual)
March 7, 2018
Last Update Submitted That Met QC Criteria
March 6, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 502008
- DN50/2008 (Other Identifier: Ethics committee at Lund university)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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