Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206843
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 27, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Triage BNP Test Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)
Study Start Date : November 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Results available Device: Triage BNP Test
No Intervention: Results blinded

Primary Outcome Measures :
  1. Length of hospital stay
  2. Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day)

Secondary Outcome Measures :
  1. Discharge BNP
  2. Change in BNP from enrollment to discharge (ΔBNP)
  3. Ratio of ΔBNP/length of stay
  4. Cost Effectiveness
  5. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206843

United States, Arizona
Chandler Regional Hospital
Chandler, Arizona, United States, 85224
United States, California
University of California, San Diego MedicalCenter
San Diego, California, United States, 92103
United States, Michigan
Detroit Receiving Hospital/Wayne State University
Detroit, Michigan, United States, 48201
Sinai Grace Hospital/Wayne State
Detroit, Michigan, United States, 48235
Beaumont Hospital, Troy
Troy, Michigan, United States, 48085
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Principal Investigator: Judd E Hollander, MD University of Pennsylvania

Responsible Party: Biosite Identifier: NCT00206843     History of Changes
Other Study ID Numbers: 005
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes