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

This study is currently recruiting participants.
Verified December 2012 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Brian Steinhart, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01193998
First received: September 1, 2010
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Dyspnea
Acute Heart Failure
Shortness of Breath
Other: Treatment as per model probability
Other: Treatment as per usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Analysis of the Impact of Using a Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clinician exposed to Model result Other: 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).
Experimental: Clinician blinded to Model result 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193998

Contacts
Contact: Brian Steinhart, MD 416-864-5095 STEINHARTB@smh.ca

Locations
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Jessica Hopkins, RN    313-745-4238      
Principal Investigator: Phillip Levy, MD         
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Brian Steinhart, MD         
New Zealand
Waikato Hospital Cardiology Clinical Trials Unit Recruiting
Waikato, New Zealand
Contact: Liz Low    07 839 7136      
Principal Investigator: Gerard Devlin, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Roche Pharma AG
Investigators
Principal Investigator: Brian Steinhart, MD St. Michael's Hospital, Toronto
Principal Investigator: David Mazer, MD St. Michael's Hospital, Toronto
Principal Investigator: Gordon Moe, MD St. Michael's Hospital, Toronto
  More Information

Publications:
Responsible Party: Brian Steinhart, Physician, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01193998     History of Changes
Other Study ID Numbers: 09-310
Study First Received: September 1, 2010
Last Updated: December 14, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Dyspnea
Emergencies
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014