Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)
- Conditions
- Heart Failure
- Interventions
- Device: Triage BNP Test
- Registration Number
- NCT00206843
- Lead Sponsor
- Abbott RDx Cardiometabolic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 630
Age 18 and older Patient needs treatment for HF
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Results available Triage BNP Test -
- Primary Outcome Measures
Name Time Method Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day) Length of hospital stay
- Secondary Outcome Measures
Name Time Method Cost Effectiveness Discharge BNP Quality of life Change in BNP from enrollment to discharge (ΔBNP) Ratio of ΔBNP/length of stay
Trial Locations
- Locations (10)
Detroit Receiving Hospital/Wayne State University
🇺🇸Detroit, Michigan, United States
Sinai Grace Hospital/Wayne State
🇺🇸Detroit, Michigan, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of California, San Diego MedicalCenter
🇺🇸San Diego, California, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Beaumont Hospital, Troy
🇺🇸Troy, Michigan, United States
Chandler Regional Hospital
🇺🇸Chandler, Arizona, United States