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BNP Testing in Patients With SOB on Presentation to ED

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2005 by Bayside Health.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163709
First Posted: September 14, 2005
Last Update Posted: October 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Alfred
Information provided by:
Bayside Health
  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
Intervention Model: Parallel Assignment
Masking: Single
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

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 11, 2005
First Posted: September 14, 2005
Last Update Posted: October 4, 2006
Last Verified: May 2005

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