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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03548909
Study type Observational
Source Ortho-Clinical Diagnostics, Inc.
Contact Stacey Alvey, MT(ASCP)SBB
Phone 908-704-3108
Email stacey.alvey@orthoclinicaldiagnostics.com
Status Recruiting
Phase
Start date June 6, 2018
Completion date August 2019

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