Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection

Heart Failure Clinical Trial

Official title: Pivotal Evaluation of the Access Natriuretic Peptdie Assay(s) as an Aid in the Diagnosis and Assessment of Severity of Acute Heart Failure - Emergency Department Subject Enrollment and Specimen Collection

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Emergencies
• Heart Failure

• NCT number: NCT04169815
• Study type: Observational
• Source: Beckman Coulter, Inc.
• Status: Completed
• Start date: November 20, 2019
• Completion date: September 30, 2022