VITROS Immunodiagnostic Products NT-proBNP II

March 5, 2020 updated by: Ortho-Clinical Diagnostics, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Drug Research Analysis Corp
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Banner - University Medical Center South Campus
    • California
      • Beverly Hills, California, United States, 90211
        • Westside Medical Associates of Los Angeles
      • Sacramento, California, United States, 95817
        • University of California Davis Health
      • San Diego, California, United States, 92093
        • University of California San Diego Health
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Hospital (Eskenazi & Methodist)
    • Louisiana
      • Zachary, Louisiana, United States, 70791
        • Southern Clinical Research
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland (Baltimore & St. Joseph)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Wayne State University (Harper)
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital (Royal Oak & Troy)
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research of South Nevada
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Charlotte-Mecklenburg Hospital Authority (Carolinas Healthcare System)
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • University of Cincinnati Physicians Company
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine (Ben Taub)
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Healthcare Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ED Setting
An acute HF population enrolled at EDs. Testing of clinical samples will be performed with the VITROS Immunodiagnostic Products NT-proBNP II assay.
Diagnostic test: VITROS Immunodiagnostic Products
NT-proBNP II assay
Outpatient Setting
A non-acute population enrolled at outpatient centers.Testing of clinical samples will be performed with the VITROS Immunodiagnostic Products NT-proBNP II assay.
Diagnostic test: VITROS Immunodiagnostic Products
NT-proBNP II assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of the VITROS NT-proBNP II assay
Time Frame: Single blood draw upon study entry 1day
Establish the performance of the VITROS NT-proBNP II assay against the adjudicated diagnosis.
Single blood draw upon study entry 1day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure Severity Assessment
Time Frame: Single blood draw upon study entry 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ortho-Clinical Diagnostics, Inc.

Investigators

  • Principal Investigator: Robert Christenson, PhD, University of Maryland, College Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2018

Primary Completion (Actual)

October 17, 2019

Study Completion (Actual)

October 17, 2019

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (Actual)

June 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-001

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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