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The goal is to establish clinical performance of a BNP assay on the intended use population and establish clinical concordance on a separate device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNP | Diagnostic 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart failure positive subjects | Subjects with BNP value above clinical decision point | Through study completion, approximately 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Heart failure negative subjects | Subjects with BNP value below clinical decision point | Through study completion, approximately 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland-Baltimore | Baltimore | Maryland | 21201 | United States | ||
| HealthPartners Central Laboratory |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2024 | May 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2024 | May 15, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Eden Prairie |
| Minnesota |
| 55344 |
| United States |
| Hennepin Healthcare Research Institute | Minneapolis | Minnesota | 55404 | United States |