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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01193998




Registration number
NCT01193998
Ethics application status
Date submitted
1/09/2010
Date registered
2/09/2010
Date last updated
16/06/2014

Titles & IDs
Public title
Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
Scientific title
Analysis of the Impact of Using a Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
Secondary ID [1] 0 0
09-310
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyspnea 0 0
Acute Heart Failure 0 0
Shortness of Breath 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Treatment as per model probability
Other interventions - Treatment as per usual care

Active Comparator: Clinician exposed to Model result -

Experimental: Clinician blinded to Model result -


Other interventions: 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).

Other interventions: 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients
Timepoint [1] 0 0
60 days after patient presentation to the emergency department
Secondary outcome [1] 0 0
Determine if use of the diagnostic prediction model leads to cost savings and better health outcomes
Timepoint [1] 0 0
From randomization until 60 days after patient presentation to the emergency department

Eligibility
Key inclusion criteria
- Age = 18 years

- Presentation to the ED with undifferentiated shortness of breath
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
186
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
New Zealand
State/province [3] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Other
Name
Unity Health Toronto
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Roche Pharma AG
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01193998
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Brian Steinhart, MD
Address 0 0
Unity Health Toronto
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01193998