BNP Testing in Patients With SOB on Presentation to ED

NCT00163709 | Unknown Phase 1

• 2 other identifiers: 116/05Heart Foundation Grant
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Congestive

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Improve long term outcomes in the Australian setting.

• Improve cost effectiveness in the Australian setting.

Interventions

BNP test PROCEDURE

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayside Health: lead
• The Alfred: collaborator

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Related Publications (2)

• 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.

  PMID: 19933409 DERIVED

• 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.

  PMID: 19293069 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hans Schneider, MBBS

  Head, Pathology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 14, 2005
• Study Start: August 1, 2005
• Last Updated: October 4, 2006

Record last verified: 2005-05

Locations

AU (1)