Access BNP Clinical Enrollment Study

Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol

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.

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.