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

Unity Health Toronto

Status: Completed

Conditions: Dyspnea; Shortness of Breath; Acute Heart Failure

Treatments: Other: Treatment as per model probability; Other: Treatment as per usual care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01193998

09-310

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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186 participants in 2 patient groups

Clinician exposed to Model result

Active Comparator group

Treatment:

Other: Treatment as per model probability

Clinician blinded to Model result

Experimental group

Treatment:

Other: Treatment as per usual care