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

NCT ID: NCT01193998

Last Updated: 2014-06-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dyspnea Acute Heart Failure Shortness of Breath

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clinician exposed to Model result

Group Type ACTIVE_COMPARATOR

Treatment as per model probability

Intervention Type 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 blinded to Model result

Group Type EXPERIMENTAL

Treatment as per usual care

Intervention Type 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.

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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Brian Steinhart

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Waikato Hospital Cardiology Clinical Trials Unit

Waikato, , New Zealand

Site Status

Countries

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United States Canada New Zealand

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.

Reference Type BACKGROUND
PMID: 15820160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12135939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17548729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19815122 (View on PubMed)

Other Identifiers

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09-310

Identifier Type: -

Identifier Source: org_study_id

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