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OpenTrials
Completed

NCT Number: NCT06624293

Access BNP Clinical Enrollment Study

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University Medical Center Department of Emergency Medicine, Loma Linda, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BNP

Diagnostic Test

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.

Primary outcomes

  1. Heart failure positive subjects

    Time frame: During initial assessment in emergency department

    Subjects with BNP value above clinical decision point

Secondary outcomes

  1. Heart failure negative subjects

    Time frame: During initial assessment in emergency department

    Subjects with BNP value below clinical decision point

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Registry information

Official study title

Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2024
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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