Clinical Research Details

Clinical Research

Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol

Study 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.

Inclusion/Exclusion Criteria

Inclusion

Ability to provide informed consent
Adult ≥ 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’s 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.

Open Enrollment

Contact Name: Morgan Manning-Henson
Contact Phone: (904) 244-4234
Contact Email: morgan.henson@jax.ufl.edu

Investigators


Christine N. Gage, D.O.
Emergency Medicine