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Clinical Trials/NCT00206843
NCT00206843
Completed
Not Applicable

Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)

Abbott RDx Cardiometabolic10 sites in 1 country630 target enrollmentNovember 2004
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Abbott RDx Cardiometabolic
Enrollment
630
Locations
10
Primary Endpoint
Length of hospital stay
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2004
End Date
August 2007
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Abbott RDx Cardiometabolic
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Length of hospital stay

Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day)

Secondary Outcomes

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

Study Sites (10)

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