Identifying High- and Low-Risk Heart Failure Patients in the Emergency Department (The Stratify Study)
Stratify
Improving Heart Failure Risk Stratification in the ED
Stratify
Improving Heart Failure Risk Stratification in the ED
Sponsor study identifier
Secondary identifiers
NIH
observational
1,033
1 country
1
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
July 26, 2007
Actual (reported)July 30, 2007
Actual (reported)December 2014
Actual (reported)December 2015
Actual (reported)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
Measured while participants are in the hospital
This will be a convenience sample of patients presenting to the emergency department for care.
University of Cincinnati
Cincinnati, Ohio, 45267-0769, United States
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.
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.
Blood
Alan B. Storrow, MD
Vanderbilt University Medical Center
1,033 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2007
First Posted
July 30, 2007
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Star-Close Early Ambulation Trial
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
April 19, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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