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

NCT01193998 | Completed DMC

• 1 other identifier: 09-310
• Study Type: interventional
• Target: 186
• Locations: 3 countries
• Sites: 3

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.

Conditions

Dyspnea; Acute Heart Failure; Shortness of Breath

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Clinician exposed to Model result

ACTIVE COMPARATOR

Other: Treatment as per model probability

Clinician blinded to Model result

EXPERIMENTAL

Other: Treatment as per usual care

Interventions

Treatment as per model probability OTHER

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 exposed to Model result

Treatment as per usual care OTHER

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.

Clinician blinded to Model result

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Presentation to the ED with undifferentiated shortness of breath

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Roche Pharma AG: collaborator

Study Sites (3)

Wayne State University

Detroit, Michigan, 48201, United States

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Waikato Hospital Cardiology Clinical Trials Unit

Waikato, New Zealand

Location

Related 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. doi: 10.1016/j.amjcard.2004.12.032.

  PMID: 15820160 BACKGROUND

• 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.

  PMID: 12135939 BACKGROUND

• 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.

  PMID: 17548729 BACKGROUND

• 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.

  PMID: 19815122 BACKGROUND

MeSH Terms

Conditions

Dyspnea

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian Steinhart, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• David Mazer, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Gordon Moe, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

NZ (1); US (1); CA (1)