Heart Failure
Conditions
Brief summary
The purpose of this study is to test whether physicians can make more informed treatment, admission, and discharge decisions related to patient care by having serial Triage® BNP test results available to assess disease severity, while patients are being treated for HF in the Emergency Department and/or during their admission. This is believed to lead to a better outcome as well as more efficient and cost-effective treatment.
Detailed description
This is a patient-randomized clinical study consisting of patients who present to the ED requiring treatment and/or admission for HF. At each site, patients will be randomized into either a control arm or an experimental arm. Serial blood samples will be collected from all patients throughout their stay in the ED and the hospital. In the experimental arm, the Triage® BNP test will be performed on all blood samples collected and each BNP result will be made available to the attending physicians immediately. In the control arm, blood samples will not be analyzed on-site for BNP but instead sent directly to Biosite Inc. for testing.A comparison will be made between the control and experimental arms of the study to determine if there are any significant differences in length of stay, re-hospitalizations, all cause mortality, BNP levels, quality of life, and costs to treat patients.
Interventions
DEVICETriage BNP Test
Sponsors
Abbott RDx Cardiometabolic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 18 and older Patient needs treatment for HF
Exclusion criteria
Current MI or ACS with ST deviation of 1 mm or greater Renal failure requiring dialysis Undergone hemodialysis within the last month Enrollment (Baseline) Triage® BNP concentration = 100 pg/ml or less Enrolled in any other drug trial or receiving an experimental treatment for HF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital stay | — |
| Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day) | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of ΔBNP/length of stay | — |
| Discharge BNP | — |
| Quality of life | — |
| Cost Effectiveness | — |
| Change in BNP from enrollment to discharge (ΔBNP) | — |
Countries
United States
Outcome results
None listed