Access BNP Clinical Performance Evaluation: Testing and Clinical Concordance Study
Access BNP on DxI 9000 Clinical Performance Evaluation: Specimen Testing and Clinical Concordance Study
1 other identifier
observational
1,361
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2025
CompletedFirst Submitted
Initial submission to the registry
June 3, 2025
CompletedFirst Posted
Study publicly available on registry
October 16, 2025
CompletedOctober 16, 2025
October 1, 2025
6 months
June 3, 2025
October 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Heart failure positive subjects
Subjects with BNP value above clinical decision point
Through study completion, approximately 9 months
Secondary Outcomes (1)
Heart failure negative subjects
Through study completion, approximately 9 months
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
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.
You may not qualify if:
- Hemolysis observed per CLSIC56A grading scale
- Icterus (bilirubin) observed 4+ per CLSIC56A grading scale
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2025
First Posted
October 16, 2025
Study Start
October 10, 2024
Primary Completion
March 25, 2025
Study Completion
March 25, 2025
Last Updated
October 16, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share