Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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.

Official Title

Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol

Keywords

Heart Failure, BNP

Eligibility

You can join if…

Open to people ages 22 years and up

  • 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)

You CAN'T join if...

  • 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.

Locations

  • UC Davis Health Department of Emergency Medicine not yet accepting patients
    Sacramento California 95817 United States
  • Loma Linda University Medical Center Department of Emergency Medicine not yet accepting patients
    Loma Linda California 92354 United States
  • Hcmc-Hhri accepting new patients
    Minneapolis Minnesota 55404 United States
  • University of Florida College of Medicine accepting new patients
    Gainesville Florida 32620 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Beckman Coulter, Inc.
ID
NCT06624293
Study Type
Observational [Patient Registry]
Participants
Expecting 1100 study participants
Last Updated