Clinical trial NCT06624293: Access BNP Clinical Enrollment Study
Official title: Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 1100
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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representation A minimum of 400 subjects with a HF positive clinical site diagnosis need to be enrolled without being withdrawn/discontinued.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 (\&gt; 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Heart failure positive subjects
timeFrame: During initial assessment in emergency department
Secondary outcomes:
measure: Heart failure negative subjects
timeFrame: During initial assessment in emergency department
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center Department of Emergency Medicine
state: California
city: Sacramento
country: United States
facility: UC Davis Health Department of Emergency Medicine
state: California
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Medicine - Jacksonville
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Department of Emergency Medicine
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Baltimore University of Maryland Medical Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Minneapolis
country: United States
facility: Hcmc-Hhri
state: Minnesota
city: Albuquerque
country: United States
facility: University of New Mexico Department of Emergency Medicine
state: New Mexico
city: Rochester
country: United States
facility: Department of Emergency Medicine University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Department of Emergency Medicine Stony Brook University Medical Center
state: New York
city: Columbus
country: United States
facility: The Ohio State College of Medicine Department of Emergency Medicine
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University School of Medicine Center for Emergency Care Research and Innovation
state: Tennessee
city: Houston
country: United States
facility: Ben Taub Hospital
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Health University Hospital
state: Wisconsin
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.