Heart Failure Clinical Trial
Official title:
VITROS Immunodiagnostic Products NT-proBNP II
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.
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.
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