VITROS Immunodiagnostic Products NT-proBNP II

Study Overview
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Brief Summary
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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
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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.

Official Title
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VITROS Immunodiagnostic Products NT-proBNP II

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: VITROS Immunodiagnostic Products


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ED Setting<br>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<br>* NT-proBNP II assay<br>|
| Outpatient Setting<br>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<br>* NT-proBNP II assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of the VITROS NT-proBNP II assay | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NT-proBNP