Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection
- Conditions
- Heart Failure
- Interventions
- Diagnostic Test: Access Immunodiagnostic Products
- Registration Number
- NCT04169815
- Lead Sponsor
- Beckman Coulter, Inc.
- Brief Summary
The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic cutoffs and assess HF severity.
- Detailed Description
A prospective clinical sample collection and future natriuretic peptide testing will be conducted in an emergency department only population. Patients presenting to the Emergency Department (ED) with signs and symptoms of acute heart failure will be approached for enrollment.
Clinical and laboratory data will be collected to establish product performance and clinical concordance to adjudicated clinical diagnosis. Approximately 1800 evaluable subjects at geographically dispersed sites in the US will be enrolled in the study.
Sample collection and testing of clinical samples with the Access Natriuretic Peptide assay will be performed under two separate protocols
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2370
- Signed and dated informed consent obtained
- Adult aged 21 years or older
- Presenting with a clinical suspicion of acute HF
- Subject clinical history available for review by Sponsor or delegates and FDA or other regulatory agencies
- Dyspnea clearly not secondary to HF (e.g. primary lung disease or chest trauma)
- Stage 4 or 5 Chronic Kidney Disease (CKD)
- Chronic dialysis
- Participation in a clinical study that may interfere with participation in this study
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ED Setting Access Immunodiagnostic Products An acute HF population enrolled at the emergency department. Testing of clinical samples will be performed with the Access natriuretic peptide assay.
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity of the future Natriuretic Peptide Assay(s) Single blood draw upon study entry at day 1 Establish the performance of the future Natriuretic Peptide assay(s) against the adjudicated diagnosis.
- Secondary Outcome Measures
Name Time Method Heart Failure Severity Assessment Single blood draw upon study entry at day 1 and two remote follow up visits Demonstrate that the Access Natriuretic Peptide Assay may be used for assessment of heart failure severity.
Trial Locations
- Locations (15)
Beckman Coulter Site AN
🇺🇸Kansas City, Kansas, United States
Beckman Coulter Site AL
🇺🇸Sacramento, California, United States
Beckman Coulter Site AB
🇺🇸Gainesville, Florida, United States
Beckman Coulter Site AA
🇺🇸Detroit, Michigan, United States
Beckman Coulter Site AI
🇺🇸Albuquerque, New Mexico, United States
Beckman Coulter Site AH
🇺🇸Saint Louis, Missouri, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Beckman Coulter Site AC
🇺🇸Charleston, South Carolina, United States
Beckman Coulter Site AD
🇺🇸Nashville, Tennessee, United States
Beckman Coulter Site AM
🇺🇸Madison, Wisconsin, United States
Beckman Coulter Site AJ
🇺🇸Loma Linda, California, United States
Beckman Coulter Site AG
🇺🇸Indianapolis, Indiana, United States
Beckman Coulter Site AE
🇺🇸Stony Brook, New York, United States
Beckman Coulter Site AK
🇺🇸Cleveland, Ohio, United States
Beckman Coulter Site AF
🇺🇸Columbus, Ohio, United States