NCT03548909

VITROS Immunodiagnostic Products NT-proBNP II

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,246 (actual)
• Sponsor: Ortho-Clinical Diagnostics, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	VITROS Immunodiagnostic Products	NT-proBNP II assay

Timeline

• Start date: 2018-06-06
• Primary completion: 2019-10-17
• Completion: 2019-10-17
• First posted: 2018-06-07
• Last updated: 2020-03-09

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated device study