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

NCT04169815 | Completed FDA Device

• 1 other identifier: HF-01-19
• Study Type: observational
• Target: 2,370
• Locations: 1 country
• Sites: 15

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.

Conditions

Heart Failure

Keywords

Natriuretic Peptide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Heart Failure Severity Assessment

  Single blood draw upon study entry at day 1 and two remote follow up visits

Study Arms (1)

ED Setting

An acute HF population enrolled at the emergency department. Testing of clinical samples will be performed with the Access natriuretic peptide assay.

Diagnostic Test: Access Immunodiagnostic Products

Interventions

Access Immunodiagnostic Products DIAGNOSTIC_TEST

Access Natriuretic Peptide Assay

ED Setting

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (15)

Beckman Coulter Site AJ

Loma Linda, California, 92354, United States

Location

Beckman Coulter Site AL

Sacramento, California, 95817, United States

Location

Beckman Coulter Site AB

Gainesville, Florida, 32608, United States

Location

Beckman Coulter Site AG

Indianapolis, Indiana, 46202, United States

Location

Beckman Coulter Site AN

Kansas City, Kansas, 66160, United States

Location

Beckman Coulter Site AA

Detroit, Michigan, 48202, United States

Location

Beckman Coulter Site AH

St Louis, Missouri, 63110, United States

Location

Beckman Coulter Site AI

Albuquerque, New Mexico, 87106, United States

Location

Beckman Coulter Site AE

Stony Brook, New York, 11794, United States

Location

Beckman Coulter Site AK

Cleveland, Ohio, 44109, United States

Location

Beckman Coulter Site AF

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97208-3003, United States

Location

Beckman Coulter Site AC

Charleston, South Carolina, 29425, United States

Location

Beckman Coulter Site AD

Nashville, Tennessee, 37235, United States

Location

Beckman Coulter Site AM

Madison, Wisconsin, 53792, United States

Location

Related Publications (8)

• 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.

  PMID: 16487838 BACKGROUND

• 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.

  PMID: 8477647 BACKGROUND

• 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.

  PMID: 15831643 BACKGROUND

• 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.

  PMID: 18549849 BACKGROUND

• 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.

  PMID: 23256914 BACKGROUND

• 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.

  PMID: 27207191 BACKGROUND

• 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.

  PMID: 16293638 BACKGROUND

• 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.

  PMID: 12124404 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Plasma sample collection

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 20, 2019
• Study Start: November 20, 2019
• Primary Completion: May 31, 2022
• Study Completion: September 30, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)