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

February 10, 2023 updated by: Beckman Coulter, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

2370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Beckman Coulter Site AJ
      • Sacramento, California, United States, 95817
        • Beckman Coulter Site AL
    • Florida
      • Gainesville, Florida, United States, 32608
        • Beckman Coulter Site AB
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Beckman Coulter Site AG
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Beckman Coulter Site AN
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Beckman Coulter Site AA
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Beckman Coulter Site AH
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Beckman Coulter Site AI
    • New York
      • Stony Brook, New York, United States, 11794
        • Beckman Coulter Site AE
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Beckman Coulter Site AK
      • Columbus, Ohio, United States, 43210
        • Beckman Coulter Site AF
    • Oregon
      • Portland, Oregon, United States, 97208-3003
        • Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Beckman Coulter Site AC
    • Tennessee
      • Nashville, Tennessee, United States, 37235
        • Beckman Coulter Site AD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Beckman Coulter Site AM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The population will be representative of an acute heart failure population enrolled at Emergency Departments. Patients presenting with a suspicion of acute heart failure will be approached for enrollment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ED Setting
An acute HF population enrolled at the emergency department. Testing of clinical samples will be performed with the Access natriuretic peptide assay.
Diagnostic test: Access Immunodiagnostic Products
Access Natriuretic Peptide Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of the future Natriuretic Peptide Assay(s)
Time Frame: Single blood draw upon study entry at day 1
Establish the performance of the future Natriuretic Peptide assay(s) against the adjudicated diagnosis.
Single blood draw upon study entry at day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure Severity Assessment
Time Frame: 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.
Single blood draw upon study entry at day 1 and two remote follow up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beckman Coulter, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2019

Primary Completion (ACTUAL)

May 31, 2022

Study Completion (ACTUAL)

September 30, 2022

Study Registration Dates

First Submitted

November 17, 2019

First Submitted That Met QC Criteria

November 17, 2019

First Posted (ACTUAL)

November 20, 2019

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF-01-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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