Clinical trial NCT01193998: Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
Official title: Analysis of the Impact of Using a Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Acute Heart Failure
Shortness of Breath
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2010-09-02
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients
timeFrame: 60 days after patient presentation to the emergency department
Secondary outcomes:
measure: Determine if use of the diagnostic prediction model leads to cost savings and better health outcomes
timeFrame: From randomization until 60 days after patient presentation to the emergency department
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Waikato
country: New Zealand
facility: Waikato Hospital Cardiology Clinical Trials Unit
Study officials:
affiliation: Unity Health Toronto
name: Brian Steinhart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: David Mazer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Gordon Moe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1161/01.cir.0000025242.79963.4c.
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. doi: 10.1161/CIRCULATIONAHA.106.666255. Epub 2007 Jun 4.
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.