Access BNP Clinical Enrollment Study

NCT06624293 | Completed FDA Device

• 1 other identifier: BNP-05-24
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 17

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Heart failure positive subjects

  Subjects with BNP value above clinical decision point

  During initial assessment in emergency department

Secondary Outcomes (1)

• Heart failure negative subjects

  During initial assessment in emergency department

Study Arms (1)

Subjects with heart failure

Targeting subjects in the acute care setting that present with suspicion of either new onset or worsening symptoms of heart failure

Diagnostic Test: BNP

Interventions

BNP DIAGNOSTIC_TEST

Blood collected during this study will be tested on separate IUO BNP assay on a separate protocol. No active interventions will occur during this study.

Subjects with heart failure

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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representation A minimum of 400 subjects with a HF positive clinical site diagnosis need to be enrolled without being withdrawn/discontinued.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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (17)

Loma Linda University Medical Center Department of Emergency Medicine

Loma Linda, California, 92354, United States

Location

UC Davis Health Department of Emergency Medicine

Sacramento, California, 95817, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32620, United States

Location

University of Florida College of Medicine - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center Department of Emergency Medicine

Kansas City, Kansas, 66160, United States

Location

University of Maryland Baltimore University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Hcmc-Hhri

Minneapolis, Minnesota, 55404, United States

Location

University of New Mexico Department of Emergency Medicine

Albuquerque, New Mexico, 87106, United States

Location

Department of Emergency Medicine University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Department of Emergency Medicine Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

The Ohio State College of Medicine Department of Emergency Medicine

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University School of Medicine Center for Emergency Care Research and Innovation

Nashville, Tennessee, 37203, United States

Location

Ben Taub Hospital

Houston, Texas, 77030, United States

Location

University of Wisconsin Health University Hospital

Madison, Wisconsin, 53792, United States

Location

Related Publications (8)

• Long B, Koyfman A, Gottlieb M. Diagnosis of Acute Heart Failure in the Emergency Department: An Evidence-Based Review. West J Emerg Med. 2019 Oct 24;20(6):875-884. doi: 10.5811/westjem.2019.9.43732.

  PMID: 31738714 BACKGROUND

• Fleg JL, Pina IL, Balady GJ, Chaitman BR, Fletcher B, Lavie C, Limacher MC, Stein RA, Williams M, Bazzarre T. Assessment of functional capacity in clinical and research applications: An advisory from the Committee on Exercise, Rehabilitation, and Prevention, Council on Clinical Cardiology, American Heart Association. Circulation. 2000 Sep 26;102(13):1591-7. doi: 10.1161/01.cir.102.13.1591. No abstract available.

  PMID: 11004153 BACKGROUND

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.

  PMID: 35379503 BACKGROUND

• Apple FS, Panteghini M, Ravkilde J, Mair J, Wu AH, Tate J, Pagani F, Christenson RH, Jaffe AS; Committee on Standardization of Markers of Cardiac Damage of the IFCC. Quality specifications for B-type natriuretic peptide assays. Clin Chem. 2005 Mar;51(3):486-93. doi: 10.1373/clinchem.2004.044594.

  PMID: 15738513 BACKGROUND

• Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Abraham WT, Wu AH, Clopton P, Steg PG, Westheim A, Knudsen CW, Perez A, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002 Jul 18;347(3):161-7. doi: 10.1056/NEJMoa020233.

  PMID: 12124404 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

  PMID: 27207191 BACKGROUND

• Friedewald VE Jr, Burnett JC Jr, Januzzi JL Jr, Roberts WC, Yancy CW. The editor's roundtable: B-type natriuretic peptide. Am J Cardiol. 2008 Jun 15;101(12):1733-40. doi: 10.1016/j.amjcard.2008.03.017. Epub 2008 Apr 22. No abstract available.

  PMID: 18549849 BACKGROUND

• Mueller T, Gegenhuber A, Poelz W, Haltmayer M. Diagnostic accuracy of B type natriuretic peptide and amino terminal proBNP in the emergency diagnosis of heart failure. Heart. 2005 May;91(5):606-12. doi: 10.1136/hrt.2004.037762.

  PMID: 15831643 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA plasma

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 2, 2024
• Study Start: August 30, 2024
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

US (17)