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Completed

NCT Number: NCT03548909

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Drug Research Analysis Corp, Montgomery, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VITROS Immunodiagnostic Products

Diagnostic Test

NT-proBNP II assay

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ortho-Clinical Diagnostics, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2018
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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