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

Primary Purpose

Dyspnea, Acute Heart Failure, Shortness of Breath

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Treatment as per model probability
Treatment as per usual care
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dyspnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wayne State University
  • St. Michael's Hospital
  • Waikato Hospital Cardiology Clinical Trials Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clinician exposed to Model result

Clinician blinded to Model result

Arm Description

Outcomes

Primary Outcome Measures

Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients

Secondary Outcome Measures

Determine if use of the diagnostic prediction model leads to cost savings and better health outcomes

Full Information

First Posted
September 1, 2010
Last Updated
June 12, 2014
Sponsor
Unity Health Toronto
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT01193998
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Acute Heart Failure, Shortness of Breath

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinician exposed to Model result
Arm Type
Active Comparator
Arm Title
Clinician blinded to Model result
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Treatment as per model probability
Intervention Description
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
Intervention Name(s)
Treatment as per usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients
Time Frame
60 days after patient presentation to the emergency department
Secondary Outcome Measure Information:
Title
Determine if use of the diagnostic prediction model leads to cost savings and better health outcomes
Time Frame
From randomization until 60 days after patient presentation to the emergency department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Steinhart, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Mazer, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gordon Moe, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Waikato Hospital Cardiology Clinical Trials Unit
City
Waikato
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
15820160
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.
Results Reference
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PubMed Identifier
12135939
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.
Results Reference
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PubMed Identifier
17548729
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.
Results Reference
background
PubMed Identifier
19815122
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.
Results Reference
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Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department

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