Heart Failure
Conditions
Keywords
NT-proBNP
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.
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.
Interventions
DIAGNOSTIC_TESTVITROS Immunodiagnostic Products
NT-proBNP II assay
Sponsors
Ortho-Clinical Diagnostics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of the VITROS NT-proBNP II assay | Single blood draw upon study entry 1day | Establish the performance of the VITROS NT-proBNP II assay against the adjudicated diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure Severity Assessment | 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. |
Countries
United States
Outcome results
None listed