Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)

Study Overview
=================
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.

Official Title
-----------------
Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Triage BNP Test


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Results available<br> | Device: Triage BNP Test<br> <br> |
| No Intervention: Results blinded<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  |  | 
| Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge BNP |  |  | 
| Change in BNP from enrollment to discharge (ΔBNP) |  |  | 
| Ratio of ΔBNP/length of stay |  |  | 
| Cost Effectiveness |  |  | 
| Quality of life |  |  |