Heart FailureNCT07217431
Access BNP Clinical Performance Evaluation: Testing and Clinical Concordance Study
An observational study of Heart Failure, run by Beckman Coulter, Inc. at 3 sites in United States.
Trial 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. 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
- 1,361 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Oct 2024to 25 Mar 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: 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.
Who may be able to join
- There is no direct inclusion criteria for this study, Samples were collected under a separate enrollment protocol
Who cannot join
- Hemolysis observed per CLSIC56A grading scale
- Icterus (bilirubin) observed 4+ per CLSIC56A grading scale
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland-Baltimore
Baltimore, Maryland, 21201
HealthPartners Central Laboratory
Eden Prairie, Minnesota, 55344
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55404
About this study
Official title: Access BNP on DxI 9000 Clinical Performance Evaluation: Specimen Testing and Clinical Concordance Study
The goal is to establish clinical performance of a BNP assay on the intended use population and establish clinical concordance on a separate device.
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: BNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with BNP value above clinical decision point
Subjects with BNP value above clinical decision point - Heart Failure Positive
Measured: 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
Measured: Through study completion, approximately 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start10 Oct 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217431
- Sponsor's protocol ID
- BNP-02-23
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access BNP on DxI 9000 Clinical Performance Evaluation: Specimen Testing and Clinical Concordance Study
- ClinicalTrials.gov ID
- NCT07217431
- Acronym / sponsor ID
- BNP-02-23
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,361 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to establish clinical performance of a BNP assay on the intended use population and establish clinical concordance on a separate device.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with heart failure | – | Diagnostic Test: BNPTargeting subjects in the acute care setting that present with suspicion of either new onset or worsening symptoms of heart failure |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- There is no direct inclusion criteria for this study, Samples were collected under a separate enrollment protocol
Key exclusion criteria (2 listed)
- Hemolysis observed per CLSIC56A grading scale
- Icterus (bilirubin) observed 4+ per CLSIC56A grading scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNPBlood collected during this study will be tested on separate IUO BNP assay on a separate protocol. No active interventions will occur during this study. | Diagnostic test | Subjects with heart failure |
Primary outcome
Number of participants with BNP value above clinical decision point
Time frame: Through study completion, approximately 9 months
Subjects with BNP value above clinical decision point - Heart Failure Positive
1 secondary outcome
Number of participants with BNP value below clinical decision point
Time frame: Through study completion, approximately 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Beckman Coulter, Inc. at 3 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 1 inclusion and 2 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Number of participants with BNP value above clinical decision point (time frame: Through study completion, approximately 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.