Clinical trial NCT03548909: VITROS Immunodiagnostic Products NT-proBNP II
Official title: VITROS Immunodiagnostic Products NT-proBNP II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: NT-proBNP
Lead sponsor: Ortho-Clinical Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-07
Enrollment: 3246
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The ED population represents an acute HF population enrolled at Emergency Departments. Patients presenting with a suspicion of HF and acute symptoms will be approached for enrollment.

The outpatient population represents a population with suspicion of HF presenting to outpatient centers. Patients presenting with a suspicion of HF will be approached for enrollment.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and Specificity of the VITROS NT-proBNP II assay
timeFrame: Single blood draw upon study entry 1day
Secondary outcomes:
measure: Heart Failure Severity Assessment
timeFrame: Single blood draw upon study entry 1 day
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Drug Research Analysis Corp
state: Alabama
city: Tucson
country: United States
facility: University of Arizona Banner - University Medical Center South Campus
state: Arizona
city: Beverly Hills
country: United States
facility: Westside Medical Associates of Los Angeles
state: California
city: Sacramento
country: United States
facility: University of California Davis Health
state: California
city: San Diego
country: United States
facility: University of California San Diego Health
state: California
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Hospital (Eskenazi & Methodist)
state: Indiana
city: Zachary
country: United States
facility: Southern Clinical Research
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland (Baltimore & St. Joseph)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University (Harper)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital (Royal Oak & Troy)
state: Michigan
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: Charlotte-Mecklenburg Hospital Authority (Carolinas Healthcare System)
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine (Ben Taub)
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Falls Church
country: United States
facility: INOVA Healthcare Services
state: Virginia
Study officials:
affiliation: University of Maryland, College Park
name: Robert Christenson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-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. No abstract available.
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. doi: 10.1161/01.cir.97.19.1921.
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. doi: 10.1016/s0022-2143(99)90163-4.
citation: 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. doi: 10.1016/s0002-9149(96)00278-0.
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. doi: 10.1016/s0140-6736(97)03034-1.