Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)

This study has been terminated.
Sponsor:
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00206843
First received: September 12, 2005
Last updated: November 1, 2006
Last verified: November 2006

September 12, 2005
November 1, 2006
November 2004
Not Provided
  • Length of hospital stay
  • Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day)
Same as current
Complete list of historical versions of study NCT00206843 on ClinicalTrials.gov Archive Site
  • Discharge BNP
  • Change in BNP from enrollment to discharge (ΔBNP)
  • Ratio of ΔBNP/length of stay
  • Cost Effectiveness
  • Quality of life
Same as current
Not Provided
Not Provided
 
Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)
Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Heart Failure
Device: Triage BNP Test
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
680
Not Provided
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00206843
005
Not Provided
Not Provided
Biosite
Not Provided
Principal Investigator: Judd E Hollander, MD University of Pennsylvania
Biosite
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP