Heart Failure
Conditions
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.
Interventions
DIAGNOSTIC_TESTBNP
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.
Sponsors
Beckman Coulter, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure positive subjects | During initial assessment in emergency department | Subjects with BNP value above clinical decision point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure negative subjects | During initial assessment in emergency department | Subjects with BNP value below clinical decision point |
Countries
United States
Outcome results
None listed