VITROS Immunodiagnostic Products NT-proBNP II
- Conditions
- Heart Failure
- Interventions
- Diagnostic Test: VITROS Immunodiagnostic Products
- Registration Number
- NCT03548909
- Lead Sponsor
- Ortho-Clinical Diagnostics, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3246
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ED Setting VITROS Immunodiagnostic Products An acute HF population enrolled at EDs. Testing of clinical samples will be performed with the VITROS Immunodiagnostic Products NT-proBNP II assay. Outpatient Setting VITROS Immunodiagnostic Products A non-acute population enrolled at outpatient centers.Testing of clinical samples will be performed with the VITROS Immunodiagnostic Products NT-proBNP II assay.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (25)
William Beaumont Hospital (Royal Oak & Troy)
🇺🇸Royal Oak, Michigan, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
University of Maryland (Baltimore & St. Joseph)
🇺🇸Baltimore, Maryland, United States
Baylor College of Medicine (Ben Taub)
🇺🇸Houston, Texas, United States
Drug Research Analysis Corp
🇺🇸Montgomery, Alabama, United States
Indiana University Health Hospital (Eskenazi & Methodist)
🇺🇸Indianapolis, Indiana, United States
Westside Medical Associates of Los Angeles
🇺🇸Beverly Hills, California, United States
University of Arizona Banner - University Medical Center South Campus
🇺🇸Tucson, Arizona, United States
Southern Clinical Research
🇺🇸Zachary, Louisiana, United States
INOVA Healthcare Services
🇺🇸Falls Church, Virginia, United States
Charlotte-Mecklenburg Hospital Authority (Carolinas Healthcare System)
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of California Davis Health
🇺🇸Sacramento, California, United States
University of California San Diego Health
🇺🇸San Diego, California, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Wayne State University (Harper)
🇺🇸Detroit, Michigan, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Cincinnati Physicians Company
🇺🇸Cincinnati, Ohio, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States