Access BNP Clinical Enrollment Study
- Conditions
- Heart Failure
- Interventions
- Diagnostic Test: BNP
- Registration Number
- NCT06624293
- Lead Sponsor
- Beckman Coulter, Inc.
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1100
- 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)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects with heart failure BNP Targeting subjects in the acute care setting that present with suspicion of either new onset or worsening symptoms of heart failure
- Primary Outcome Measures
Name Time Method Heart failure positive subjects During initial assessment in emergency department Subjects with BNP value above clinical decision point
- Secondary Outcome Measures
Name Time Method Heart failure negative subjects During initial assessment in emergency department Subjects with BNP value below clinical decision point
Trial Locations
- Locations (17)
Loma Linda University Medical Center Department of Emergency Medicine
🇺🇸Loma Linda, California, United States
University of Florida College of Medicine - Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Maryland Baltimore University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
UC Davis Health Department of Emergency Medicine
🇺🇸Sacramento, California, United States
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Henry Ford Health
🇺🇸Detroit, Michigan, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
University of Kansas Medical Center Department of Emergency Medicine
🇺🇸Kansas City, Kansas, United States
Hcmc-Hhri
🇺🇸Minneapolis, Minnesota, United States
University of New Mexico Department of Emergency Medicine
🇺🇸Albuquerque, New Mexico, United States
Department of Emergency Medicine University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Department of Emergency Medicine Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
The Ohio State College of Medicine Department of Emergency Medicine
🇺🇸Columbus, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt University School of Medicine Center for Emergency Care Research and Innovation
🇺🇸Nashville, Tennessee, United States
Ben Taub Hospital
🇺🇸Houston, Texas, United States
University of Wisconsin Health University Hospital
🇺🇸Madison, Wisconsin, United States