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Sponsors and Collaborators: |
Bayside Health The Alfred |
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Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00163709 |
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.
Condition | Intervention | Phase |
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Heart Failure, Congestive |
Procedure: BNP test |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised Trial of BNP Testing in Patients With Shortness of Breath in the Emergency Department to Improve Patient Outcome |
Estimated Enrollment: | 600 |
Study Start Date: | August 2005 |
In recent years new tests to diagnose heart failure have become available. We are evaluating a new test called B-type natriuretic peptide(BNP)in patients presenting to the Emergency Department with shortness of breath.
Patients are randomised into whether they will receive the new test or not. In the patient group where the test is positive, standardised approach that will optimise heart failure treatment will be introduced. We hypothesise that with this approach we will improve the clinical care of patients who present to the Emergency Department with shortness of breath. Measures of outcomes will be the accuracy of diagnosis 2 hours after presentation, 30 day mortality, hospital and ICU admission rates and quality of life at 30days.
We plan to investigate 600 consecutive patient presenting to the to the Emergency Department with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher.
Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease, patients with cardiogenic shock and patients who have early transfer to another hospital(within 24 hrs) will be excluded.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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.
Australia, Victoria | |
Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3004 | |
Contact: Hans G Schneider, Associate Professor 613 9276 3118 schneiderh@alfred.org.au | |
Contact: Peter Cameron, Professor 613 9276 2000 peter.cameron@med.monash.edu.au | |
Principal Investigator: Hans G Schneider, MD FRCPA FRACP | |
Sub-Investigator: Peter Cameron, MBBS,MD,FACEM | |
Sub-Investigator: Henry Krum, MBBS,PhD,FRACP |
Principal Investigator: | Hans Schneider, MBBS | Head, Pathology Department |
Study ID Numbers: | 116/05, Heart Foundation Grant |
Study First Received: | September 11, 2005 |
Last Updated: | October 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00163709 History of Changes |
Health Authority: | Australia: National Health and Medical Research Council |
Atrial natriuretic factor. Biochemistry. Cardiac failure. Randomised trials. Hormones. |
Systolic heart failure. Diastolic heart failure. Ischaemic cardiomyopathy. Ventricular hypertrophy. AMI |
Hypertrophy Heart Failure, Diastolic Heart Failure Heart Diseases Emergencies |
Ischemia Hormones Cardiomyopathies Dyspnea Heart Failure, Systolic |
Heart Failure Heart Diseases Cardiovascular Diseases |