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OpenTrials
Completed

NCT Number: NCT01193998

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

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.

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Key information

Conditions

Dyspnea Acute Heart Failure Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Shortness of Breath Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as per model probability

Other

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).

Treatment as per usual care

Other

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.

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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2010
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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