Clinical trial NCT00508638: Identifying High- and Low-Risk Heart Failure Patients in the Emergency Department (The Stratify Study)
Official title: Improving Heart Failure Risk Stratification in the ED
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Heart Failure
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Cincinnati
First posted: 2007-07-30
Enrollment: 1033
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be a convenience sample of patients presenting to the emergency department for care.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Information collected from participants while in the hospital, including a digital heart sound recording procedure, a medical record review, blood collection, and a brief cognitive assessment
timeFrame: Measured while participants are in the hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alan B. Storrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collins SP, Hart KW, Lindsell CJ, Fermann GJ, Weintraub NL, Miller KF, Roll SN, Sperling MI, Sawyer DB, Storrow AB. Elevated urinary neutrophil gelatinase-associated lipocalcin after acute heart failure treatment is associated with worsening renal function and adverse events. Eur J Heart Fail. 2012 Sep;14(9):1020-9. doi: 10.1093/eurjhf/hfs087. Epub 2012 Jun 25.
citation: Collins SP, Lindsell CJ, Storrow AB, Fermann GJ, Levy PD, Pang PS, Weintraub N, Frank Peacock W, Sawyer DB, Gheorghiade M. Early changes in clinical characteristics after emergency department therapy for acute heart failure syndromes: identifying patients who do not respond to standard therapy. Heart Fail Rev. 2012 May;17(3):387-94. doi: 10.1007/s10741-011-9294-7.
citation: Pang PS, Collins SP, Storrow AB. Letter by Pang et al regarding article, "Early deaths in heart failure patients discharged from the emergency department: a population-based analysis". Circ Heart Fail. 2010 Jul;3(4):e22; author reply e23. doi: 10.1161/CIRCHEARTFAILURE.110.945865. No abstract available.
citation: Collins SP, Lindsell CJ, Yealy DM, Maron DJ, Naftilan AJ, McPherson JA, Storrow AB. A comparison of criterion standard methods to diagnose acute heart failure. Congest Heart Fail. 2012 Sep-Oct;18(5):262-71. doi: 10.1111/j.1751-7133.2012.00288.x. Epub 2012 Apr 4.
citation: Doering A, Jenkins CA, Storrow AB, Lindenfeld J, Fermann GJ, Miller KF, Sperling M, Collins SP. Markers of diuretic resistance in emergency department patients with acute heart failure. Int J Emerg Med. 2017 Dec;10(1):17. doi: 10.1186/s12245-017-0143-x. Epub 2017 May 8.
citation: Collins SP, Jenkins CA, Harrell FE Jr, Liu D, Miller KF, Lindsell CJ, Naftilan AJ, McPherson JA, Maron DJ, Sawyer DB, Weintraub NL, Fermann GJ, Roll SK, Sperling M, Storrow AB. Identification of Emergency Department Patients With Acute Heart Failure at Low Risk for 30-Day Adverse Events: The STRATIFY Decision Tool. JACC Heart Fail. 2015 Oct;3(10):737-47. doi: 10.1016/j.jchf.2015.05.007.
citation: Collins SP, Lindsell CJ, Jenkins CA, Harrell FE, Fermann GJ, Miller KF, Roll SN, Sperling MI, Maron DJ, Naftilan AJ, McPherson JA, Weintraub NL, Sawyer DB, Storrow AB. Risk stratification in acute heart failure: rationale and design of the STRATIFY and DECIDE studies. Am Heart J. 2012 Dec;164(6):825-34. doi: 10.1016/j.ahj.2012.07.033. Epub 2012 Oct 29.