Access BNP Assay Clinical Subject Sample Collection Enrollment StudyProtocol
B
Benton Hunter, MD
Primary Investigator
Enrolling By Invitation
22 years - 100 years
All
Phase
N/A
150 participants needed
1 Location
Brief description of study
What is the purpose of this 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.
Detailed description of study
What will happen during the study?
- Targeting subjects in the acute care setting that present with suspicion of either new onset or worsening symptoms of heart failure
- 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Heart Failure
-
Age: 22 years - 100 years
-
Gender: All
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.
Updated on
07 Jan 2025.
Study ID: EMER-BECKMAN-BNP-05-24, 25208
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