Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Clinician exposed to Model result
|
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).
|
| Experimental: Clinician blinded to Model result
|
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Presentation to the ED with undifferentiated shortness of breath
Exclusion Criteria:
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Dyspnea of obvious cause, e.g. chest trauma, obvious clinical exacerbation of known chronic obstructive disease
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Obvious pulmonary edema in a patient with a known diagnosis of HF and recently admitted to hospital for HF
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Clinician does not plan to treat for AHF at all, but rather to pursue other causes of dyspnea (i.e., probability of AHF ≤ 20%)
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Clinician plans to treat for AHF and not to pursue other causes of dyspnea (i.e., probability of AHF ≥ 80%)
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Acute coronary syndrome within one month
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Chronic renal failure (serum creatinine ≥ 250 mol/l)
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Anticipated life expectancy < 6 months due to non-cardiovascular causes
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Participation in another interventional outcome trial
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Inability to obtain informed consent, including inability of patient to understand English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wayne State University | Detroit | Michigan | United States | 48201 |
| 2 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
| 3 | Waikato Hospital Cardiology Clinical Trials Unit | Waikato | New Zealand |
Sponsors and Collaborators
- Unity Health Toronto
- Roche Pharma AG
Investigators
- Principal Investigator: Brian Steinhart, MD, Unity Health Toronto
- Principal Investigator: David Mazer, MD, Unity Health Toronto
- Principal Investigator: Gordon Moe, MD, Unity Health Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 09-310