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VITROS Immunodiagnostic Products NT-proBNP II

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ClinicalTrials.gov Identifier: NCT03548909
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ortho-Clinical Diagnostics, Inc.

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.

Condition or disease Intervention/treatment
Heart Failure Diagnostic Test: VITROS Immunodiagnostic Products

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.


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Study Type : Observational
Estimated Enrollment : 4300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: VITROS Immunodiagnostic Products NT-proBNP II
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Serum, Lithium Heparin, and EDTA


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548909


Contacts
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Contact: Stacey Alvey, MT(ASCP)SBB 908-704-3108 stacey.alvey@orthoclinicaldiagnostics.com
Contact: Duane Dey, BS 908-218-8578 duane.dey@orthoclinicaldiagnostics.com

  Show 25 Study Locations
Sponsors and Collaborators
Ortho-Clinical Diagnostics, Inc.
Investigators
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Principal Investigator: Robert Christenson, PhD University of Maryland, College Park

Publications:

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Responsible Party: Ortho-Clinical Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT03548909     History of Changes
Other Study ID Numbers: 16-001
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Ortho-Clinical Diagnostics, Inc.:
NT-proBNP

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases