Acute Heart Failure, Dyspnea, Shortness of Breath
Conditions
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.
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.
Sponsors
Roche Pharma AG
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, New Zealand, United States
Outcome results
None listed