Clinical trial NCT04169815: Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection
Official title: Pivotal Evaluation of the Access Natriuretic Peptdie Assay(s) as an Aid in the Diagnosis and Assessment of Severity of Acute Heart Failure - Emergency Department Subject Enrollment and Specimen Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Natriuretic Peptide
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 2370
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population will be representative of an acute heart failure population enrolled at Emergency Departments. Patients presenting with a suspicion of acute heart failure will be approached for enrollment.

Brief summary: The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic cutoffs and assess HF severity.

Detailed description: A prospective clinical sample collection and future natriuretic peptide testing will be conducted in an emergency department only population. Patients presenting to the Emergency Department (ED) with signs and symptoms of acute heart failure will be approached for enrollment.

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

Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent obtained
* 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:

* Dyspnea clearly not secondary to HF (e.g. primary lung disease or chest trauma)
* 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.

Primary outcomes:
measure: Sensitivity and Specificity of the future Natriuretic Peptide Assay(s)
timeFrame: Single blood draw upon study entry at day 1
Secondary outcomes:
measure: Heart Failure Severity Assessment
timeFrame: Single blood draw upon study entry at day 1 and two remote follow up visits
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Beckman Coulter Site AJ
state: California
city: Sacramento
country: United States
facility: Beckman Coulter Site AL
state: California
city: Gainesville
country: United States
facility: Beckman Coulter Site AB
state: Florida
city: Indianapolis
country: United States
facility: Beckman Coulter Site AG
state: Indiana
city: Kansas City
country: United States
facility: Beckman Coulter Site AN
state: Kansas
city: Detroit
country: United States
facility: Beckman Coulter Site AA
state: Michigan
city: Saint Louis
country: United States
facility: Beckman Coulter Site AH
state: Missouri
city: Albuquerque
country: United States
facility: Beckman Coulter Site AI
state: New Mexico
city: Stony Brook
country: United States
facility: Beckman Coulter Site AE
state: New York
city: Cleveland
country: United States
facility: Beckman Coulter Site AK
state: Ohio
city: Columbus
country: United States
facility: Beckman Coulter Site AF
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Charleston
country: United States
facility: Beckman Coulter Site AC
state: South Carolina
city: Nashville
country: United States
facility: Beckman Coulter Site AD
state: Tennessee
city: Madison
country: United States
facility: Beckman Coulter Site AM
state: Wisconsin
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.