Access BNP Clinical Enrollment Study

NCT ID: NCT06624293

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-30

Study Completion Date

2025-02-18

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

BNP

Intervention Type 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.

Interventions

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BNP

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beckman Coulter, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Loma Linda University Medical Center Department of Emergency Medicine

Loma Linda, California, United States

Site Status

UC Davis Health Department of Emergency Medicine

Sacramento, California, United States

Site Status

University of Florida College of Medicine

Gainesville, Florida, United States

Site Status

University of Florida College of Medicine - Jacksonville

Jacksonville, Florida, United States

Site Status

Indiana University Health

Indianapolis, Indiana, United States

Site Status

University of Kansas Medical Center Department of Emergency Medicine

Kansas City, Kansas, United States

Site Status

University of Maryland Baltimore University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Henry Ford Health

Detroit, Michigan, United States

Site Status

Hcmc-Hhri

Minneapolis, Minnesota, United States

Site Status

University of New Mexico Department of Emergency Medicine

Albuquerque, New Mexico, United States

Site Status

Department of Emergency Medicine University of Rochester Medical Center

Rochester, New York, United States

Site Status

Department of Emergency Medicine Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

The Ohio State College of Medicine Department of Emergency Medicine

Columbus, Ohio, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

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

Nashville, Tennessee, United States

Site Status

Ben Taub Hospital

Houston, Texas, United States

Site Status

University of Wisconsin Health University Hospital

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31738714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11004153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35379503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15738513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12124404 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27207191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18549849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15831643 (View on PubMed)

Other Identifiers

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BNP-05-24

Identifier Type: -

Identifier Source: org_study_id

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