Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department

Dyspnea Clinical Trial

Official title:

Analysis of the Impact of Using a Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193998
• Other study ID #: 09-310
• Status: Completed
• Phase: N/A
• First received: September 1, 2010
• Last updated: June 12, 2014
• Start date: September 2010
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate a validated diagnostic prediction model in the appropriate diagnosis of Acute Heart Failure (AHF) in patients presenting at the emergency department with undifferentiated dyspnea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Presentation to the ED with undifferentiated shortness of breath

Exclusion Criteria:

• Dyspnea of obvious cause, e.g. chest trauma, obvious clinical exacerbation of known chronic obstructive disease

• Obvious pulmonary edema in a patient with a known diagnosis of HF and recently admitted to hospital for HF

• Clinician does not plan to treat for AHF at all, but rather to pursue other causes of dyspnea (i.e., probability of AHF = 20%)

• Clinician plans to treat for AHF and not to pursue other causes of dyspnea (i.e., probability of AHF = 80%)

• Acute coronary syndrome within one month

• Chronic renal failure (serum creatinine = 250 mol/l)

• Anticipated life expectancy < 6 months due to non-cardiovascular causes

• Participation in another interventional outcome trial

• Inability to obtain informed consent, including inability of patient to understand English

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Heart Failure
• Dyspnea
• Heart Failure
• Shortness of Breath

Intervention

Other:
• Treatment as per model probability
Patients randomized to the arm where the clinician is exposed to the model results should be treated as per the model probability (i.e. if the model probability suggests AHF the clinician should treat for AHF).
• Treatment as per usual care
Patients randomized to the arm where the clinician is blinded to the model results will undergo diagnostic tests and receive treatment as per the clinician's judgment and usual care standards.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
New Zealand	Waikato Hospital Cardiology Clinical Trials Unit	Waikato
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Roche Pharma AG

Countries where clinical trial is conducted

United States,  Canada,  New Zealand, 

References & Publications (4)

Januzzi JL Jr, Camargo CA, Anwaruddin S, Baggish AL, Chen AA, Krauser DG, Tung R, Cameron R, Nagurney JT, Chae CU, Lloyd-Jones DM, Brown DF, Foran-Melanson S, Sluss PM, Lee-Lewandrowski E, Lewandrowski KB. The N-terminal Pro-BNP investigation of dyspnea in the emergency department (PRIDE) study. Am J Cardiol. 2005 Apr 15;95(8):948-54. — View Citation

McCullough PA, Nowak RM, McCord J, Hollander JE, Herrmann HC, Steg PG, Duc P, Westheim A, Omland T, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AH, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002 Jul 23;106(4):416-22. — View Citation

Moe GW, Howlett J, Januzzi JL, Zowall H; Canadian Multicenter Improved Management of Patients With Congestive Heart Failure (IMPROVE-CHF) Study Investigators. N-terminal pro-B-type natriuretic peptide testing improves the management of patients with suspected acute heart failure: primary results of the Canadian prospective randomized multicenter IMPROVE-CHF study. Circulation. 2007 Jun 19;115(24):3103-10. Epub 2007 Jun 4. — View Citation

Steinhart B, Thorpe KE, Bayoumi AM, Moe G, Januzzi JL Jr, Mazer CD. Improving the diagnosis of acute heart failure using a validated prediction model. J Am Coll Cardiol. 2009 Oct 13;54(16):1515-21. doi: 10.1016/j.jacc.2009.05.065. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients		60 days after patient presentation to the emergency department	No
Secondary	Determine if use of the diagnostic prediction model leads to cost savings and better health outcomes		From randomization until 60 days after patient presentation to the emergency department	No