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

NCT00508638 | Completed

• 3 other identifiers: 508R01HL088459R01 HL055459
• Study Type: observational
• Target: 1,033
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This will be a convenience sample of patients presenting to the emergency department for care.

You may qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Cincinnati: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0769, United States

Location

Related Publications (7)

• 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.

  PMID: 22733980 BACKGROUND

• 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.

  PMID: 22160814 BACKGROUND

• 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.

  PMID: 20647481 BACKGROUND

• 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.

  PMID: 22994440 RESULT

• 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.

  PMID: 28484958 DERIVED

• 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.

  PMID: 26449993 DERIVED

• 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.

  PMID: 23194482 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Alan B. Storrow, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman for Research and Academic Affairs

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)