Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)
1 other identifier
interventional
630
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Nov 2004
Typical duration for not_applicable heart-failure
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedJuly 27, 2015
July 1, 2015
2.4 years
September 12, 2005
July 23, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Length of hospital stay
Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day)
Secondary Outcomes (5)
Discharge BNP
Change in BNP from enrollment to discharge (ΔBNP)
Ratio of ΔBNP/length of stay
Cost Effectiveness
Quality of life
Study Arms (2)
Results available
EXPERIMENTALResults blinded
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Age 18 and older Patient needs treatment for HF
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Chandler Regional Hospital
Chandler, Arizona, 85224, United States
University of California, San Diego MedicalCenter
San Diego, California, 92103, United States
Detroit Receiving Hospital/Wayne State University
Detroit, Michigan, 48201, United States
Sinai Grace Hospital/Wayne State
Detroit, Michigan, 48235, United States
Beaumont Hospital, Troy
Troy, Michigan, 48085, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judd E Hollander, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 21, 2005
Study Start
November 1, 2004
Primary Completion
April 1, 2007
Study Completion
August 1, 2007
Last Updated
July 27, 2015
Record last verified: 2015-07