Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection
NCT ID: NCT04169815
Last Updated: 2023-02-14
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
2370 participants
OBSERVATIONAL
2019-11-20
2022-09-30
Brief Summary
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Detailed Description
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Clinical and laboratory data will be collected to establish product performance and clinical concordance to adjudicated clinical diagnosis. Approximately 1800 evaluable subjects at geographically dispersed sites in the US will be enrolled in the study.
Sample collection and testing of clinical samples with the Access Natriuretic Peptide assay will be performed under two separate protocols
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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ED Setting
An acute HF population enrolled at the emergency department. Testing of clinical samples will be performed with the Access natriuretic peptide assay.
Access Immunodiagnostic Products
Access Natriuretic Peptide Assay
Interventions
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Access Immunodiagnostic Products
Access Natriuretic Peptide Assay
Eligibility Criteria
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Inclusion Criteria
* Adult aged 21 years or older
* Presenting with a clinical suspicion of acute HF
* Subject clinical history available for review by Sponsor or delegates and FDA or other regulatory agencies
Exclusion Criteria
* Stage 4 or 5 Chronic Kidney Disease (CKD)
* Chronic dialysis
* Participation in a clinical study that may interfere with participation in this study
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
21 Years
ALL
No
Sponsors
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Beckman Coulter, Inc.
INDUSTRY
Responsible Party
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Locations
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Beckman Coulter Site AJ
Loma Linda, California, United States
Beckman Coulter Site AL
Sacramento, California, United States
Beckman Coulter Site AB
Gainesville, Florida, United States
Beckman Coulter Site AG
Indianapolis, Indiana, United States
Beckman Coulter Site AN
Kansas City, Kansas, United States
Beckman Coulter Site AA
Detroit, Michigan, United States
Beckman Coulter Site AH
St Louis, Missouri, United States
Beckman Coulter Site AI
Albuquerque, New Mexico, United States
Beckman Coulter Site AE
Stony Brook, New York, United States
Beckman Coulter Site AK
Cleveland, Ohio, United States
Beckman Coulter Site AF
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Beckman Coulter Site AC
Charleston, South Carolina, United States
Beckman Coulter Site AD
Nashville, Tennessee, United States
Beckman Coulter Site AM
Madison, Wisconsin, United States
Countries
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References
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Iwanaga Y, Nishi I, Furuichi S, Noguchi T, Sase K, Kihara Y, Goto Y, Nonogi H. B-type natriuretic peptide strongly reflects diastolic wall stress in patients with chronic heart failure: comparison between systolic and diastolic heart failure. J Am Coll Cardiol. 2006 Feb 21;47(4):742-8. doi: 10.1016/j.jacc.2005.11.030. Epub 2006 Jan 26.
Kinnunen P, Vuolteenaho O, Ruskoaho H. Mechanisms of atrial and brain natriuretic peptide release from rat ventricular myocardium: effect of stretching. Endocrinology. 1993 May;132(5):1961-70. doi: 10.1210/endo.132.5.8477647.
Mueller T, Gegenhuber A, Poelz W, Haltmayer M. Diagnostic accuracy of B type natriuretic peptide and amino terminal proBNP in the emergency diagnosis of heart failure. Heart. 2005 May;91(5):606-12. doi: 10.1136/hrt.2004.037762.
Friedewald VE Jr, Burnett JC Jr, Januzzi JL Jr, Roberts WC, Yancy CW. The editor's roundtable: B-type natriuretic peptide. Am J Cardiol. 2008 Jun 15;101(12):1733-40. doi: 10.1016/j.amjcard.2008.03.017. Epub 2008 Apr 22. No abstract available.
O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 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 J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
Januzzi JL, van Kimmenade R, Lainchbury J, Bayes-Genis A, Ordonez-Llanos J, Santalo-Bel M, Pinto YM, Richards M. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 Feb;27(3):330-7. doi: 10.1093/eurheartj/ehi631. Epub 2005 Nov 17.
Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Abraham WT, Wu AH, Clopton P, Steg PG, Westheim A, Knudsen CW, Perez A, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002 Jul 18;347(3):161-7. doi: 10.1056/NEJMoa020233.
Other Identifiers
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HF-01-19
Identifier Type: -
Identifier Source: org_study_id
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