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Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triage BNP Test
Sponsored by
Biosite
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chandler Regional Hospital
  • University of California, San Diego MedicalCenter
  • Detroit Receiving Hospital/Wayne State University
  • Sinai Grace Hospital/Wayne State
  • Beaumont Hospital, Troy
  • New York Methodist Hospital
  • Stony Brook University Hospital
  • Duke University Hospital
  • Wake Forest University Baptist Medical Center
  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Results available

Results blinded

Arm Description

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
July 23, 2015
Sponsor
Biosite
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1. Study Identification

Unique Protocol Identification Number
NCT00206843
Brief Title
Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)
Official Title
Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosite

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Results available
Arm Type
Experimental
Arm Title
Results blinded
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Triage BNP Test
Primary Outcome Measure Information:
Title
Length of hospital stay
Title
Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day)
Secondary Outcome Measure Information:
Title
Discharge BNP
Title
Change in BNP from enrollment to discharge (ΔBNP)
Title
Ratio of ΔBNP/length of stay
Title
Cost Effectiveness
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judd E Hollander, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chandler Regional Hospital
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
University of California, San Diego MedicalCenter
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Detroit Receiving Hospital/Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Sinai Grace Hospital/Wayne State
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
Facility Name
Beaumont Hospital, Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)

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