Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169815
• Other study ID #: HF-01-19
• Status: Completed
• Start date: November 20, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2023
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2370
• Est. completion date: September 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Heart Failure

Intervention

Diagnostic Test:
• Access Immunodiagnostic Products
Access Natriuretic Peptide Assay

Locations

Country	Name	City	State
United States	Beckman Coulter Site AI	Albuquerque	New Mexico
United States	Beckman Coulter Site AC	Charleston	South Carolina
United States	Beckman Coulter Site AK	Cleveland	Ohio
United States	Beckman Coulter Site AF	Columbus	Ohio
United States	Beckman Coulter Site AA	Detroit	Michigan
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 AJ	Loma Linda	California
United States	Beckman Coulter Site AM	Madison	Wisconsin
United States	Beckman Coulter Site AD	Nashville	Tennessee
United States	Oregon Health and Science University	Portland	Oregon
United States	Beckman Coulter Site AL	Sacramento	California
United States	Beckman Coulter Site AH	Saint Louis	Missouri
United States	Beckman Coulter Site AE	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of the future Natriuretic Peptide Assay(s)	Establish the performance of the future Natriuretic Peptide assay(s) against the adjudicated diagnosis.	Single blood draw upon study entry at day 1
Secondary	Heart Failure Severity Assessment	Demonstrate that the Access Natriuretic Peptide Assay may be used for assessment of heart failure severity.	Single blood draw upon study entry at day 1 and two remote follow up visits