ClinicalTrials.gg
CompletedNCT01193998Updated Jun 16, 2014

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

An interventional study of Treatment as per model probability and Treatment as per usual care in Dyspnea, Acute Heart Failure and Shortness of Breath, sponsored by Unity Health Toronto. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-16.

Sponsored by Unity Health Toronto · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dyspnea
  • Acute Heart Failure
  • Shortness of Breath

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03

In context

Dyspnea

681 studies on the registry are indexed under Dyspnea; 159 are open to participants now.

This study's enrollment of 186 is above the median of 48 across 447 interventional studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 444 studies on the registry; 80 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
186 participants (actual)

Study arms

  • Active comparator
    Clinician exposed to Model result

    Other: Treatment as per model probability

  • Experimental
    Clinician blinded to Model result

    Other: Treatment as per usual care

Interventions

  • OtherTreatment 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).

  • OtherTreatment 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.

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

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Study locations

3 sites
  • Wayne State University
    Detroit, Michigan 48201, United States
  • St. Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
  • Waikato Hospital Cardiology Clinical Trials Unit
    Waikato, New Zealand
08

References and documents

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. PubMed 15820160 ↗
  • 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. PubMed 12135939 ↗
  • 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. PubMed 17548729 ↗
  • 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. PubMed 19815122 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2010, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2010
First posted
Sep 2, 2010
Start
Sep 2010
Primary completionActual
Jun 2014
CompletionActual
Jun 2014
Last update
Jun 16, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01193998
Collaborators
Roche Pharma AG
Responsible party
Brian Steinhart (Physician, Unity Health Toronto) — Principal investigator
First posted
Sep 2, 2010
Start date
Sep 2010
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Jun 16, 2014

Study contacts

Brian Steinhart, MD
principal investigator · Unity Health Toronto
David Mazer, MD
principal investigator · Unity Health Toronto
Gordon Moe, MD
principal investigator · Unity Health Toronto

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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