NCT Number: NCT00206843
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Chandler Regional Hospital, Chandler, Arizona, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Length of hospital stay
-
Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day)
Secondary outcomes
-
Discharge BNP
-
Change in BNP from enrollment to discharge (ΔBNP)
-
Ratio of ΔBNP/length of stay
-
Cost Effectiveness
-
Quality of life
Sponsors and collaborators
Lead sponsor
Abbott RDx Cardiometabolic
Other
Registry information
Important dates
- Study start
- 2004
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Sep 21, 2005
- Registry last updated
- Jul 27, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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