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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00163709
Registration number
NCT00163709
Ethics application status
Date submitted
11/09/2005
Date registered
14/09/2005
Date last updated
4/10/2006
Titles & IDs
Public title
BNP Testing in Patients With SOB on Presentation to ED
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Scientific title
A Randomised Trial of BNP Testing in Patients With Shortness of Breath in the Emergency Department to Improve Patient Outcome
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Secondary ID [1]
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Heart Foundation Grant
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Secondary ID [2]
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116/05
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Congestive
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Allow more accurate diagnosis of heart failure.
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Cause a change of management.
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Assessment method [2]
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Timepoint [2]
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Primary outcome [3]
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Benefit some patients presenting with shortness fo breath more than others.
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Assessment method [3]
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Timepoint [3]
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Primary outcome [4]
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Increse the use of early Continuous Positive Airway Pressure (CPAP) ventilation, nitrates, loop diuretics and ACE inhibitors.
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Assessment method [4]
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Timepoint [4]
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Primary outcome [5]
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Decrease hospital stay.
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Assessment method [5]
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Timepoint [5]
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Primary outcome [6]
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Decrease hospital admission rate.
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Assessment method [6]
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Timepoint [6]
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Primary outcome [7]
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Decrease the number of endotracheal intubations.
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Assessment method [7]
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Timepoint [7]
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Primary outcome [8]
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Decrease 30-day mortality.
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Assessment method [8]
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Timepoint [8]
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Secondary outcome [1]
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Improve long term outcomes in the Australian setting.
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Improve cost effectiveness in the Australian setting.
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Assessment method [2]
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Timepoint [2]
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Eligibility
Key inclusion criteria
We plan to include all patients presenting to the ED with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease (serum creatinine level of more than 250 micro mmol/L, patients with cardiogenic shock, and patients who have an early transfer to another hospital (within 24 hrs) will be excluded.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2005
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Alfred
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
A trial to examine whether a new heart failure blood test can improve the outcome of patients presenting to the Emergency Department with shortness of breath. We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency Department with shortness of breath will help identify additional patients with CHF and consequently to change practice and allow more patients to recieve correct treatment earlier.
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Trial website
https://clinicaltrials.gov/study/NCT00163709
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Trial related presentations / publications
Lokuge A, Lam L, Cameron P, Krum H, de Villiers S, Bystrzycki A, Naughton MT, Eccleston D, Flannery G, Federman J, Schneider HG. B-type natriuretic peptide testing and the accuracy of heart failure diagnosis in the emergency department. Circ Heart Fail. 2010 Jan;3(1):104-10. doi: 10.1161/CIRCHEARTFAILURE.109.869438. Epub 2009 Nov 20. Schneider HG, Lam L, Lokuge A, Krum H, Naughton MT, De Villiers Smit P, Bystrzycki A, Eccleston D, Federman J, Flannery G, Cameron P. B-type natriuretic peptide testing, clinical outcomes, and health services use in emergency department patients with dyspnea: a randomized trial. Ann Intern Med. 2009 Mar 17;150(6):365-71. doi: 10.7326/0003-4819-150-6-200903170-00004.
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Public notes
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Contacts
Principal investigator
Name
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Hans Schneider, MBBS
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Address
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Head, Pathology Department
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Fax
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00163709
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