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.

This study is expected to enroll approximately 1,100 subjects from intended use population. The study population (enrolled by the collective clinical sites) should reasonably represent the U.S. demographic population. Sponsor will monitor for age, race, gender representation A minimum of 400 subjects with a HF positive clinical site diagnosis need to be enrolled without being withdrawn/discontinued. Of the HF positive group, the sample size for severity assessment (> 80% power) requires a minimum of 340 subjects with a minimum of 50, 150, and 140 NYHA class II, III, and IV subjects, respectively, to detect a correlation between BNP level increase and the severity of heart failure.