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Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol

  • Status
    Accepting Candidates
  • Age
    22 Years - 100 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

To validate a comparison of test results on intended use population samples on the IUO Access BNP Assay on DxI 9000 to the predicate assay in support of global regulatory submissions.

Details

Protocol number WCG0042333

Eligibility

Inclusion Ability to provide informed consent

Adult 鈮� 22 years old, any gender, race, ethnicity

Presenting with a clinical suspicion of new onset or worsening symptoms of heart failure.

Ability to fulfill study data collection requirements (including NYHA evaluation questions) Exclusion Individuals < 22 years old

Impairment in individual鈥檚 capacity to give informed consent

Dyspnea clearly not secondary to heart failure (e.g., primary lung disease or chest trauma).

Stage 4 or 5 Chronic Kidney Disease (CKD)

On chronic 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.

Lead researchers

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.