Identifying High- and Low-Risk Heart Failure Patients in the Emergency Department (The Stratify Study)



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/20/2017
Start Date:May 2007
End Date:December 2015

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Improving Heart Failure Risk Stratification in the ED

People with heart failure (HF) symptoms who are seen in the emergency department (ED) are
often admitted to the hospital even though it may not be necessary. This study will gather
information from HF patients seen in the ED to develop a decision-making tool that will help
doctors predict the risk of HF-related death or serious complications. Improving the ability
of ED doctors to effectively and safely manage low-risk HF patients should lead to fewer
unnecessary hospitalizations.

HF is a life-threatening condition in which the heart can no longer pump enough blood to the
rest of the body. Symptoms of HF can include shortness of breath, nausea, fatigue, swelling
of the feet or abdomen, and an irregular or rapid pulse. A critical challenge facing ED
doctors is how to best manage people who come into the ED with symptoms of HF. Currently,
most people evaluated for HF in the ED are admitted to the hospital; however, not all of
these people are in need of such intensive treatment. It is estimated that up to 50% of
HF-related hospital admissions could be avoided. Improving the ability of the ED doctor to
effectively and safely manage low-risk HF patients is essential to avoid unnecessary
hospitalizations. This study will gather information from ED patients at risk for HF to
develop an algorithm decision tool that will predict patients' risk for inpatient or
outpatient death and serious complications from HF. This decision tool will be distributed
worldwide for ED use and will hopefully reduce the costs of HF care by appropriately
allocating hospital resources.

This study will enroll adults admitted to the ED with possible signs of HF. While in the ED,
participants will undergo a digital heart sound recording procedure, a medical record
review, blood collection, and a brief cognitive assessment. Five and 30 days following the
ED visit, participants will be contacted by phone or will be visited in the hospital by
study staff. Information will be collected on health status and unplanned hospital or ED
visits that have occurred following the initial ED visit.

Inclusion Criteria:

- Admitted to the adult ED with difficulty breathing, peripheral edema, or fatigue

- Meets Framingham criteria for congestive heart failure

- Willing and able to give informed consent; this will be determined based on
participants' ability to remain in a conscious state, ability to remain awake,
ability to ask questions about the study or answer questions that are asked, and
ability to date and sign a consent form.
We found this trial at
1
site
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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