ClinicalTrials.gg
CompletedNCT07217431Updated Oct 6, 2026

Access BNP Clinical Performance Evaluation: Testing and Clinical Concordance Study

An observational study in Heart Failure, sponsored by Beckman Coulter, Inc.. Completed at 3 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Beckman Coulter, Inc. (part of Danaher Corporation) · Observational

Updated Oct 6, 2026Primary outcomes revisedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1,361
Ages
22 Years and older
Sex
All
01

Study summary

The goal is to establish clinical performance of a BNP assay on the intended use population and establish clinical concordance on a separate device.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's enrollment of 1,361 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Beckman Coulter, Inc. is the lead sponsor of 31 studies on the registry; 1 is open to participants now.

First submitted after Beckman Coulter, Inc. became part of Danaher Corporation.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Specimens are to be collected under BNP-05-24 protocol are used. Approximately 1100 K2 EDTA samples with concentrations that span the analytical measuring range (AMR) are used in this testing study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • There is no direct inclusion criteria for this study, Samples were collected under a separate enrollment protocol

Exclusion criteria

Exclusion Criteria:

  • Hemolysis observed per CLSIC56A grading scale
  • Icterus () observed 4+ per CLSIC56A grading scale
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1,361 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Diagnostic Test: BNP

Interventions

  • Diagnostic testBNP

    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.

06

What researchers measure

Primary outcomes

  1. Number of participants with BNP value above clinical decision point

    Subjects with BNP value above clinical decision point - Heart Failure Positive

    Time frame: Through study completion, approximately 9 months

Secondary outcomes

  1. Number of participants with BNP value below clinical decision point

    Subjects with BNP value below clinical decision point - Heart failure negative subjects

    Time frame: Through study completion, approximately 9 months

07

Study locations

3 sites
  • University of Maryland-Baltimore
    Baltimore, Maryland 21201, United States
  • HealthPartners Central Laboratory
    Eden Prairie, Minnesota 55344, United States
  • Hennepin Healthcare Research Institute
    Minneapolis, Minnesota 55404, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore Heart failure positive subjectsNow Number of participants with BNP value above clinical decision pointTime frame: Through study completion, approximately 9 months
Oct 6, 2026
Secondary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore Heart failure negative subjectsNow Number of participants with BNP value below clinical decision pointTime frame: Through study completion, approximately 9 months
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Heart failure positive subjectsNow Number of participants with BNP value above clinical decision pointTime frame: Through study completion, approximately 9 months
    Secondary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Heart failure negative subjectsNow Number of participants with BNP value below clinical decision pointTime frame: Through study completion, approximately 9 months
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07217431
Responsible party
Sponsor
First posted
Oct 16, 2025
Start date
Oct 10, 2024
Primary completion
Mar 25, 2025
Completion
Mar 25, 2025
Last update
Oct 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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