Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
NCT ID: NCT01193998
Last Updated: 2014-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
186 participants
INTERVENTIONAL
2010-09-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Clinician exposed to Model result
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).
Clinician blinded to Model result
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Presentation to the ED with undifferentiated shortness of breath
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Unity Health Toronto
OTHER
Responsible Party
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Brian Steinhart
Physician
Principal Investigators
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Brian Steinhart, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
David Mazer, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Gordon Moe, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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Wayne State University
Detroit, Michigan, United States
St. Michael's Hospital
Toronto, Ontario, Canada
Waikato Hospital Cardiology Clinical Trials Unit
Waikato, , New Zealand
Countries
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References
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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. doi: 10.1016/j.amjcard.2004.12.032.
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. doi: 10.1161/01.cir.0000025242.79963.4c.
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. doi: 10.1161/CIRCULATIONAHA.106.666255. 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.
Other Identifiers
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09-310
Identifier Type: -
Identifier Source: org_study_id
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