Heart Failure Clinical Trial

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

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.

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Full 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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 is for people with:

Heart Failure

Estimated Enrollment:

2370

Study ID:

NCT04169815

Recruitment Status:

Completed

Sponsor:

Beckman Coulter, Inc.

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There are 15 Locations for this study

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Beckman Coulter Site AJ
Loma Linda California, 92354, United States
Beckman Coulter Site AL
Sacramento California, 95817, United States
Beckman Coulter Site AB
Gainesville Florida, 32608, United States
Beckman Coulter Site AG
Indianapolis Indiana, 46202, United States
Beckman Coulter Site AN
Kansas City Kansas, 66160, United States
Beckman Coulter Site AA
Detroit Michigan, 48202, United States
Beckman Coulter Site AH
Saint Louis Missouri, 63110, United States
Beckman Coulter Site AI
Albuquerque New Mexico, 87106, United States
Beckman Coulter Site AE
Stony Brook New York, 11794, United States
Beckman Coulter Site AK
Cleveland Ohio, 44109, United States
Beckman Coulter Site AF
Columbus Ohio, 43210, United States
Oregon Health and Science University
Portland Oregon, 97208, United States
Beckman Coulter Site AC
Charleston South Carolina, 29425, United States
Beckman Coulter Site AD
Nashville Tennessee, 37235, United States
Beckman Coulter Site AM
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

2370

Study ID:

NCT04169815

Recruitment Status:

Completed

Sponsor:


Beckman Coulter, Inc.

How clear is this clinincal trial information?

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