Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol

Beckman Coulter, Inc.17 sites in 1 country1,100 target enrollmentAugust 30, 2024

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Beckman Coulter, Inc.
Enrollment: 1100
Locations: 17
Primary Endpoint: Heart failure positive subjects
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 30, 2024

End Date

February 18, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Beckman Coulter, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.