Study Results
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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COMPLETED
1100 participants
OBSERVATIONAL
2024-08-30
2025-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
ALL
No
Sponsors
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Beckman Coulter, Inc.
INDUSTRY
Responsible Party
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Locations
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Loma Linda University Medical Center Department of Emergency Medicine
Loma Linda, California, United States
UC Davis Health Department of Emergency Medicine
Sacramento, California, United States
University of Florida College of Medicine
Gainesville, Florida, United States
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, United States
Indiana University Health
Indianapolis, Indiana, United States
University of Kansas Medical Center Department of Emergency Medicine
Kansas City, Kansas, United States
University of Maryland Baltimore University of Maryland Medical Center
Baltimore, Maryland, United States
Henry Ford Health
Detroit, Michigan, 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
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BNP-05-24
Identifier Type: -
Identifier Source: org_study_id
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