Clinical trial NCT00206843: Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)
Official title: Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Length of hospital stay
measure: Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day)
Secondary outcomes:
measure: Discharge BNP
measure: Change in BNP from enrollment to discharge (ΔBNP)
measure: Ratio of ΔBNP/length of stay
measure: Cost Effectiveness
measure: Quality of life
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Regional Hospital
state: Arizona
city: San Diego
country: United States
facility: University of California, San Diego MedicalCenter
state: California
city: Detroit
country: United States
facility: Detroit Receiving Hospital/Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Sinai Grace Hospital/Wayne State
state: Michigan
city: Troy
country: United States
facility: Beaumont Hospital, Troy
state: Michigan
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Judd E Hollander, MD
role: PRINCIPAL_INVESTIGATOR
References: