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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
History of Changes
  Purpose

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 Intervention Phase
Heart Failure
 Device: Triage BNP Test
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Biosite:

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

Secondary Outcome Measures:
  • Discharge BNP
  • Change in BNP from enrollment to discharge (ΔBNP)
  • Ratio of ΔBNP/length of stay
  • Cost Effectiveness
  • Quality of life

Estimated Enrollment: 680
Study Start Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206843

Locations
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
Biosite
Investigators
Principal Investigator: Judd E Hollander, MD University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00206843     History of Changes
Other Study ID Numbers: 005
Study First Received: September 12, 2005
Last Updated: November 1, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013