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Heart FailureNCT04169815

Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection

An observational study of Heart Failure, run by Beckman Coulter, Inc. at 15 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 purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic cutoffs and assess HF severity. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Heart Failure
What is being tested?
Access Immunodiagnostic Products
How many people
2,370 participants
Where
15 sitesUnited States
Study dates
20 Nov 2019to 30 Sep 2022
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The population will be representative of an acute heart failure population enrolled at Emergency Departments. Patients presenting with a suspicion of acute heart failure will be approached for enrollment.

Who may be able to join

  • Signed and dated informed consent obtained
  • Adult aged 21 years or older
  • Presenting with a clinical suspicion of acute HF
  • Subject clinical history available for review by Sponsor or delegates and FDA or other regulatory agencies

Who cannot join

  • Dyspnea clearly not secondary to HF (e.g. primary lung disease or chest trauma)
  • Stage 4 or 5 Chronic Kidney Disease (CKD)
  • Chronic dialysis
  • Participation in a clinical study that may interfere with participation in this study
  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Beckman Coulter Site AI

    Albuquerque, New Mexico, 87106

  • Beckman Coulter Site AC

    Charleston, South Carolina, 29425

  • Beckman Coulter Site AK

    Cleveland, Ohio, 44109

  • Beckman Coulter Site AF

    Columbus, Ohio, 43210

  • Beckman Coulter Site AA

    Detroit, Michigan, 48202

  • Beckman Coulter Site AB

    Gainesville, Florida, 32608

  • Beckman Coulter Site AG

    Indianapolis, Indiana, 46202

  • Beckman Coulter Site AN

    Kansas City, Kansas, 66160

  • Beckman Coulter Site AJ

    Loma Linda, California, 92354

  • Beckman Coulter Site AM

    Madison, Wisconsin, 53792

  • Beckman Coulter Site AD

    Nashville, Tennessee, 37235

  • Oregon Health and Science University

    Portland, Oregon, 97208-3003

  • Beckman Coulter Site AL

    Sacramento, California, 95817

  • Beckman Coulter Site AH

    St Louis, Missouri, 63110

  • Beckman Coulter Site AE

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: Pivotal Evaluation of the Access Natriuretic Peptdie Assay(s) as an Aid in the Diagnosis and Assessment of Severity of Acute Heart Failure - Emergency Department Subject Enrollment and Specimen Collection

The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic cutoffs and assess HF severity.

Read the detailed description

A prospective clinical sample collection and future natriuretic peptide testing will be conducted in an emergency department only population. Patients presenting to the Emergency Department (ED) with signs and symptoms of acute heart failure will be approached for enrollment.

Clinical and laboratory data will be collected to establish product performance and clinical concordance to adjudicated clinical diagnosis. Approximately 1800 evaluable subjects at geographically dispersed sites in the US will be enrolled in the study.

Sample collection and testing of clinical samples with the Access Natriuretic Peptide assay will be performed under two separate protocols

Conditions
Heart Failure
Being tested
Access Immunodiagnostic Products
Keywords
Natriuretic Peptide
Medical subject headings
Heart Failure

What participants receive

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

  • Access Immunodiagnostic ProductsDiagnostic test

    Access Natriuretic Peptide Assay

Study groups in NCT04169815
Study groupRoleWhat they receive
ED SettingAn acute HF population enrolled at the emergency department. Testing of clinical samples will be performed with the Access natriuretic peptide assay.
Receives: Diagnostic Test: Access Immunodiagnostic Products

What is being measured

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

  1. Sensitivity and Specificity of the future Natriuretic Peptide Assay(s)

    Establish the performance of the future Natriuretic Peptide assay(s) against the adjudicated diagnosis.

    Measured: Single blood draw upon study entry at day 1

Secondary outcomes (1)

  1. Heart Failure Severity Assessment

    Demonstrate that the Access Natriuretic Peptide Assay may be used for assessment of heart failure severity.

    Measured: Single blood draw upon study entry at day 1 and two remote follow up visits

Timeline

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

  1. First posted20 Nov 2019
  2. Study start20 Nov 2019
  3. Primary completion31 May 2022
  4. Study completion30 Sep 2022

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
Other
Time perspective
Prospective
Enrolment
2,370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04169815
Sponsor's protocol ID
HF-01-19
Status last verified
Feb 2023
First submitted
17 Nov 2019
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Iwanaga Y, Nishi I, Furuichi S, Noguchi T, Sase K, Kihara Y, Goto Y, Nonogi H. B-type natriuretic peptide strongly reflects diastolic wall stress in patients with chronic heart failure: comparison between systolic and diastolic heart failure. J Am Coll Cardiol. 2006 Feb 21;47(4):742-8. doi: 10.1016/j.jacc.2005.11.030. Epub 2006 Jan 26.

    PubMed 16487838

  • Kinnunen P, Vuolteenaho O, Ruskoaho H. Mechanisms of atrial and brain natriuretic peptide release from rat ventricular myocardium: effect of stretching. Endocrinology. 1993 May;132(5):1961-70. doi: 10.1210/endo.132.5.8477647.

    PubMed 8477647

  • 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

  • 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

  • O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.

    PubMed 23256914

  • 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

  • Januzzi JL, van Kimmenade R, Lainchbury J, Bayes-Genis A, Ordonez-Llanos J, Santalo-Bel M, Pinto YM, Richards M. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 Feb;27(3):330-7. doi: 10.1093/eurheartj/ehi631. Epub 2005 Nov 17.

    PubMed 16293638

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Beckman Coulter, Inc. at 15 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 5 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 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

Sensitivity and Specificity of the future Natriuretic Peptide Assay(s) (time frame: Single blood draw upon study entry at day 1). 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 NCT04169815, 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 14 Feb 2023.

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