VITROS Immunodiagnostic Products NT-proBNP II

Heart Failure Clinical Trial

Official title:

VITROS Immunodiagnostic Products NT-proBNP II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03548909
• Other study ID #: 16-001
• Status: Completed
• Start date: June 6, 2018
• Est. completion date: October 17, 2019

Study information

• Verified date: March 2020
• Source: Ortho-Clinical Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Amino Terminal pro-Brain Natriuretic Peptide (NTproBNP) is secreted in conditions of cardiac wall stress. NTproBNP levels are used in addition to clinical assessment to diagnose heart failure (HF). The purpose of this clinical study is to collect data to substantiate the use of the VITROS NT-proBNP II assay.

Description:

A prospective clinical sample collection and NT-proBNP testing will be conducted in two populations. Patients presenting to the Emergency Department (ED) and patients presenting to outpatient centers will be approached for enrollment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3246
• Est. completion date: October 17, 2019
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Acute HF Population (ED setting):

Inclusion Criteria:

• Subjects must have suspicion of HF and acute symptoms at presentation.

• Subjects must be at least 22 years of age.

• Subjects must be willing and able to provide informed consent.

Exclusion Criteria:

• Acute symptoms clearly not secondary to HF.

• Subjects with renal disease on dialysis.

• Subjects unable to comply with the study requirements.

Population with suspicion of HF (Outpatient Setting):

Inclusion Criteria:

• 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:

• 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• VITROS Immunodiagnostic Products
NT-proBNP II assay

Locations

Country	Name	City	State
United States	University of Maryland (Baltimore & St. Joseph)	Baltimore	Maryland
United States	Westside Medical Associates of Los Angeles	Beverly Hills	California
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Charlotte-Mecklenburg Hospital Authority (Carolinas Healthcare System)	Charlotte	North Carolina
United States	University of Cincinnati Physicians Company	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Wayne State University (Harper)	Detroit	Michigan
United States	Northwestern University	Evanston	Illinois
United States	INOVA Healthcare Services	Falls Church	Virginia
United States	Baylor College of Medicine (Ben Taub)	Houston	Texas
United States	Indiana University Health Hospital (Eskenazi & Methodist)	Indianapolis	Indiana
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	Drug Research Analysis Corp	Montgomery	Alabama
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	William Beaumont Hospital (Royal Oak & Troy)	Royal Oak	Michigan
United States	University of California Davis Health	Sacramento	California
United States	Sun Research Institute	San Antonio	Texas
United States	University of California San Diego Health	San Diego	California
United States	University of Arizona Banner - University Medical Center South Campus	Tucson	Arizona
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	Southern Clinical Research	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ortho-Clinical Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-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. Erratum in: Eur Heart J. 2016 Dec 30;:. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of the VITROS NT-proBNP II assay	Establish the performance of the VITROS NT-proBNP II assay against the adjudicated diagnosis.	Single blood draw upon study entry 1day
Secondary	Heart Failure Severity Assessment	Demonstrate that the VITROS NT-proBNP II assay may be used for assessment of heart failure severity.	Single blood draw upon study entry 1 day