Access BNP Clinical Enrollment Study

April 18, 2025 updated by: Beckman Coulter, Inc.

Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol

The goal of this study is to collect blood from subjects with a suspicion of either new onset or worsened heart failure to be used for testing studies for a new product to aid in the diagnosis of heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1100

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
        • Loma Linda University Medical Center Department of Emergency Medicine
      • Sacramento, California, United States, 95817
        • UC Davis Health Department of Emergency Medicine
    • Florida
      • Gainesville, Florida, United States, 32620
        • University of Florida College of Medicine
      • Jacksonville, Florida, United States, 32209
        • University of Florida College of Medicine - Jacksonville
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Department of Emergency Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Baltimore University of Maryland Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Hcmc-Hhri
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Department of Emergency Medicine
    • New York
      • Rochester, New York, United States, 14642
        • Department of Emergency Medicine University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794
        • Department of Emergency Medicine Stony Brook University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State College of Medicine Department of Emergency Medicine
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University School of Medicine Center for Emergency Care Research and Innovation
    • Texas
      • Houston, Texas, United States, 77030
        • Ben Taub Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Health University Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study is expected to enroll approximately 1,100 subjects from intended use population. The study population (enrolled by the collective clinical sites) should reasonably represent the U.S. demographic population. Sponsor will monitor for age, race, gender representation A minimum of 400 subjects with a HF positive clinical site diagnosis need to be enrolled without being withdrawn/discontinued. Of the HF positive group, the sample size for severity assessment (> 80% power) requires a minimum of 340 subjects with a minimum of 50, 150, and 140 NYHA class II, III, and IV subjects, respectively, to detect a correlation between BNP level increase and the severity of heart failure.

Description

Inclusion Criteria:

  • Ability to provide informed consent
  • Adult greater than or equal to 22 years old, any gender, race, ethnicity
  • Presenting with clinical suspicion of new onset heart failure or worsening symptoms suggestive of decompensated or exacerbated heart failure
  • Ability to fulfill study data collection requirements (including responding to questions for the NYHA evaluation)

Exclusion Criteria:

  • Individuals less than 22 years old
  • Impairment in individual's capacity to give informed consent
  • Dyspnea clearly not secondary to heart failure (e.g., primary lung disease or chest trauma).
  • On dialysis
  • On nesiritide infusion
  • Subject clinical/medical history access is not available to Sponsor, delegates, and FDA or other regulatory agencies upon request.
  • Active participation in a clinical study that may interfere with participation in this study (e.g., investigational drug study)
  • Reason(s) determined by the Principal Investigator that would place the individual at increased risk or preclude the individual from fully complying with or completing 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
Subjects with heart failure
Targeting subjects in the acute care setting that present with suspicion of either new onset or worsening symptoms of heart failure
Diagnostic test: BNP
Blood collected during this study will be tested on separate IUO BNP assay on a separate protocol. No active interventions will occur during this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure positive subjects
Time Frame: During initial assessment in emergency department
Subjects with BNP value above clinical decision point
During initial assessment in emergency department

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure negative subjects
Time Frame: During initial assessment in emergency department
Subjects with BNP value below clinical decision point
During initial assessment in emergency department

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)

August 30, 2024

Primary Completion (Actual)

February 18, 2025

Study Completion (Actual)

February 18, 2025

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BNP-05-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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