BNP Testing in Patients With SOB on Presentation to ED

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Alfred
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163709
First received: September 11, 2005
Last updated: October 3, 2006
Last verified: May 2005
  Purpose

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
Heart Failure, Congestive
Procedure: BNP test
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: A Randomised Trial of BNP Testing in Patients With Shortness of Breath in the Emergency Department to Improve Patient Outcome

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • 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:
  • Improve long term outcomes in the Australian setting.
  • Improve cost effectiveness in the Australian setting.

Estimated Enrollment: 600
Study Start Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00163709

Locations
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         
Sponsors and Collaborators
Bayside Health
The Alfred
Investigators
Principal Investigator: Hans Schneider, MBBS Head, Pathology Department
  More Information

No publications provided by Bayside Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00163709     History of Changes
Other Study ID Numbers: 116/05, Heart Foundation Grant
Study First Received: September 11, 2005
Last Updated: October 3, 2006
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
Atrial natriuretic factor.
Biochemistry.
Cardiac failure.
Randomised trials.
Hormones.
Systolic heart failure.
Diastolic heart failure.
Ischaemic cardiomyopathy.
Ventricular hypertrophy.
AMI

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 15, 2014