Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3246 participants
OBSERVATIONAL
2018-06-06
2019-10-17
Brief Summary
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Detailed Description
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Clinical and laboratory data will be collected to demonstrate product performance compared to adjudicated clinical diagnosis. Approximately 4300 evaluable subjects at geographically dispersed sites in the US will be enrolled in the study.
Sample collection and testing of clinical samples with the VITROS NT-proBNP II assay will be performed under two separate protocols.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ED Setting
An acute HF population enrolled at EDs. Testing of clinical samples will be performed with the VITROS Immunodiagnostic Products NT-proBNP II assay.
VITROS Immunodiagnostic Products
NT-proBNP II assay
Outpatient Setting
A non-acute population enrolled at outpatient centers.Testing of clinical samples will be performed with the VITROS Immunodiagnostic Products NT-proBNP II assay.
VITROS Immunodiagnostic Products
NT-proBNP II assay
Interventions
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VITROS Immunodiagnostic Products
NT-proBNP II assay
Eligibility Criteria
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Inclusion Criteria
* Subjects must be at least 22 years of age.
* Subjects must be willing and able to provide informed consent.
* Subjects must be at least 22 years of age.
* Subjects must be willing and able to provide informed consent.
* Subjects who present to outpatient centers with suspicion HF.
Exclusion Criteria
* Subjects with renal disease on dialysis.
* Subjects unable to comply with the study requirements.
Population with suspicion of HF (Outpatient Setting):
* Symptoms clearly not secondary to HF.
* Subjects with renal disease on dialysis.
* Subjects unable to comply with the study requirements.
* Subjects previously diagnosed with heart failure.
22 Years
ALL
No
Sponsors
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Ortho-Clinical Diagnostics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Christenson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, College Park
Locations
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Drug Research Analysis Corp
Montgomery, Alabama, United States
University of Arizona Banner - University Medical Center South Campus
Tucson, Arizona, United States
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
University of California Davis Health
Sacramento, California, United States
University of California San Diego Health
San Diego, California, United States
Northwestern University
Evanston, Illinois, United States
Indiana University Health Hospital (Eskenazi & Methodist)
Indianapolis, Indiana, United States
Southern Clinical Research
Zachary, Louisiana, United States
University of Maryland (Baltimore & St. Joseph)
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Wayne State University (Harper)
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
William Beaumont Hospital (Royal Oak & Troy)
Royal Oak, Michigan, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
Montefiore Medical Center
The Bronx, New York, United States
Charlotte-Mecklenburg Hospital Authority (Carolinas Healthcare System)
Charlotte, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine (Ben Taub)
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
INOVA Healthcare Services
Falls Church, Virginia, United States
Countries
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References
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Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
Richards AM, Nicholls MG, Yandle TG, Frampton C, Espiner EA, Turner JG, Buttimore RC, Lainchbury JG, Elliott JM, Ikram H, Crozier IG, Smyth DW. Plasma N-terminal pro-brain natriuretic peptide and adrenomedullin: new neurohormonal predictors of left ventricular function and prognosis after myocardial infarction. Circulation. 1998 May 19;97(19):1921-9. doi: 10.1161/01.cir.97.19.1921.
Valli N, Gobinet A, Bordenave L. Review of 10 years of the clinical use of brain natriuretic peptide in cardiology. J Lab Clin Med. 1999 Nov;134(5):437-44. doi: 10.1016/s0022-2143(99)90163-4.
Darbar D, Davidson NC, Gillespie N, Choy AM, Lang CC, Shyr Y, McNeill GP, Pringle TH, Struthers AD. Diagnostic value of B-type natriuretic peptide concentrations in patients with acute myocardial infarction. Am J Cardiol. 1996 Aug 1;78(3):284-7. doi: 10.1016/s0002-9149(96)00278-0.
McDonagh TA, Robb SD, Murdoch DR, Morton JJ, Ford I, Morrison CE, Tunstall-Pedoe H, McMurray JJ, Dargie HJ. Biochemical detection of left-ventricular systolic dysfunction. Lancet. 1998 Jan 3;351(9095):9-13. doi: 10.1016/s0140-6736(97)03034-1.
Daniels LB, Ajongwen P, Christenson RH, Clark CL, Diercks DB, Fermann GJ, Mace SE, Mahler SA, Pang PS, Rafique Z, Runyon MS, Tauras J, deFilippi CR. Clinical Performance of an N-Terminal Pro-B-Type Natriuretic Peptide Assay in Acute Heart Failure Diagnosis. J Appl Lab Med. 2025 Mar 3;10(2):325-338. doi: 10.1093/jalm/jfae107.
Other Identifiers
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16-001
Identifier Type: -
Identifier Source: org_study_id
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