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.
Brief Title
VITROS Immunodiagnostic Products NT-proBNP II
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Failure
Eligibility 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.
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.
Inclusion Criteria
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.
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.
* 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.
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.
Gender
All
Gender Based
false
Keywords
NT-proBNP
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
22 Years
NCT Id
NCT03548909
Org Class
Industry
Org Full Name
Ortho-Clinical Diagnostics, Inc.
Org Study Id
16-001
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
VITROS Immunodiagnostic Products NT-proBNP II
Primary Outcomes
Outcome Description
Establish the performance of the VITROS NT-proBNP II assay against the adjudicated diagnosis.
Outcome Measure
Sensitivity and Specificity of the VITROS NT-proBNP II assay
Outcome Time Frame
Single blood draw upon study entry 1day
Secondary Outcomes
Outcome Description
Demonstrate that the VITROS NT-proBNP II assay may be used for assessment of heart failure severity.
Outcome Time Frame
Single blood draw upon study entry 1 day
Outcome Measure
Heart Failure Severity Assessment
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
22
Investigators
Investigator Type
Principal Investigator
Investigator Name
James Tauras
Investigator Email
jtauras@montefiore.org
Investigator Phone