Purpose

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

Eligibility

Eligible Ages
Over 22 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461
Contact:
Kairee Navarro
718-904-2067

More Details

Status
Recruiting
Sponsor
Ortho-Clinical Diagnostics, Inc.

Study Contact

Stacey Alvey, MT(ASCP)SBB
908-704-3108
stacey.alvey@orthoclinicaldiagnostics.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.