BNP Testing in Patients With SOB on Presentation to ED

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure, Congestive

Keywords

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Atrial natriuretic factor. Biochemistry. Cardiac failure. Randomised trials. Hormones. Systolic heart failure. Diastolic heart failure. Ischaemic cardiomyopathy. Ventricular hypertrophy. AMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

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BNP test

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Hans Schneider, MBBS

Role: PRINCIPAL_INVESTIGATOR

Head, Pathology Department

Locations

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Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Facility Contacts

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Hans G Schneider, Associate Professor

Role: primary

Peter Cameron, Professor

Role: backup

References

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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.

Reference Type DERIVED

PMID: 19933409 (View on PubMed)

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.