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

Not Applicable

Completed

• Conditions: Dyspnea; Acute Heart Failure; Shortness of Breath
• Interventions: Other: Treatment as per model probability; Other: Treatment as per usual care

• Registration Number: NCT01193998
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-12
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinician exposed to Model result	Treatment as per model probability	-
Clinician blinded to Model result	Treatment as per usual care	-

Primary Outcome Measures

Name	Time	Method
Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients	60 days after patient presentation to the emergency department

Secondary Outcome Measures

Name	Time	Method
Determine if use of the diagnostic prediction model leads to cost savings and better health outcomes	From randomization until 60 days after patient presentation to the emergency department

Trial Locations

Locations (3)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Waikato Hospital Cardiology Clinical Trials Unit; 🇳🇿 Waikato, New Zealand