Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosite
ClinicalTrials.gov Identifier:
NCT00206843
First received: September 12, 2005
Last updated: July 23, 2015
Last verified: July 2015

September 12, 2005
July 23, 2015
November 2004
April 2007   (final data collection date for primary outcome measure)
  • Length of hospital stay [ Designated as safety issue: No ]
  • Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day) [ Designated as safety issue: No ]
  • Length of hospital stay
  • Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day)
Complete list of historical versions of study NCT00206843 on ClinicalTrials.gov Archive Site
  • Discharge BNP [ Designated as safety issue: No ]
  • Change in BNP from enrollment to discharge (ΔBNP) [ Designated as safety issue: No ]
  • Ratio of ΔBNP/length of stay [ Designated as safety issue: No ]
  • Cost Effectiveness [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Discharge BNP
  • Change in BNP from enrollment to discharge (ΔBNP)
  • Ratio of ΔBNP/length of stay
  • Cost Effectiveness
  • Quality of life
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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Heart Failure
Device: Triage BNP Test
  • Experimental: Results available
    Intervention: Device: Triage BNP Test
  • No Intervention: Results blinded
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
630
August 2007
April 2007   (final data collection date for primary outcome measure)

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
No
Biosite
Biosite
Not Provided
Principal Investigator: Judd E Hollander, MD University of Pennsylvania
Biosite
July 2015

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