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Heart FailureNCT06624293

Access BNP Clinical Enrollment Study

An observational study of Heart Failure, run by Beckman Coulter, Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Heart Failure
What is being tested?
BNP
How many people
1,100 participants
Where
17 sitesUnited States
Study dates
30 Aug 2024to 18 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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representation A minimum of 400 subjects with a HF positive clinical site diagnosis need to be enrolled without being withdrawn/discontinued.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

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • University of New Mexico Department of Emergency Medicine

    Albuquerque, New Mexico, 87106

  • University of Maryland Baltimore University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Ohio State College of Medicine Department of Emergency Medicine

    Columbus, Ohio, 43210

  • Henry Ford Health

    Detroit, Michigan, 48202

  • University of Florida College of Medicine

    Gainesville, Florida, 32620

  • Ben Taub Hospital

    Houston, Texas, 77030

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • University of Florida College of Medicine - Jacksonville

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center Department of Emergency Medicine

    Kansas City, Kansas, 66160

  • Loma Linda University Medical Center Department of Emergency Medicine

    Loma Linda, California, 92354

  • University of Wisconsin Health University Hospital

    Madison, Wisconsin, 53792

  • Hcmc-Hhri

    Minneapolis, Minnesota, 55404

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

    Nashville, Tennessee, 37203

  • Department of Emergency Medicine University of Rochester Medical Center

    Rochester, New York, 14642

  • UC Davis Health Department of Emergency Medicine

    Sacramento, California, 95817

  • Department of Emergency Medicine Stony Brook University Medical Center

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol

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
Being tested
BNP
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNPDiagnostic 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.

Study groups in NCT06624293
Study groupRoleWhat they receive
Subjects with heart failureTargeting subjects in the acute care setting that present with suspicion of either new onset or worsening symptoms of heart failure
Receives: Diagnostic Test: BNP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart failure positive subjects

    Subjects with BNP value above clinical decision point

    Measured: During initial assessment in emergency department

Secondary outcomes (1)

  1. Heart failure negative subjects

    Subjects with BNP value below clinical decision point

    Measured: During initial assessment in emergency department

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start30 Aug 2024
  3. Primary completion18 Feb 2025
  4. Study completion18 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06624293
Sponsor's protocol ID
BNP-05-24
Status last verified
Apr 2025
First submitted
18 Sep 2024
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31738714

  • 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.

    PubMed 11004153

  • 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.

    PubMed 35379503

  • 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.

    PubMed 15738513

  • 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.

    PubMed 12124404

  • 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.

    PubMed 27207191

  • 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.

    PubMed 18549849

  • 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.

    PubMed 15831643

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Beckman Coulter, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart failure positive subjects (time frame: During initial assessment in emergency department). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06624293, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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Access BNP Clinical Enrollment Study (NCT06624293) | AzTrials