BNP Testing in Patients With SOB on Presentation to ED

Phase 1

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00163709
• Lead Sponsor: Bayside Health

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2005-05
• Study Start: 2005-08
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-14
• Last Update Submitted: 2006-10-03
• Last Update Posted: 2006-10-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Allow more accurate diagnosis of heart failure.
Cause a change of management.
Benefit some patients presenting with shortness fo breath more than others.
Increse the use of early Continuous Positive Airway Pressure (CPAP) ventilation, nitrates, loop diuretics and ACE inhibitors.
Decrease hospital stay.
Decrease hospital admission rate.
Decrease the number of endotracheal intubations.
Decrease 30-day mortality.

Secondary Outcome Measures

Name	Time	Method
Improve long term outcomes in the Australian setting.
Improve cost effectiveness in the Australian setting.

Trial Locations

Locations (1)

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia