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Completed

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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Key information

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

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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

Triage BNP Test

Device

Primary outcomes

  1. Length of hospital stay

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

Secondary outcomes

  1. Discharge BNP

  2. Change in BNP from enrollment to discharge (ΔBNP)

  3. Ratio of ΔBNP/length of stay

  4. Cost Effectiveness

  5. 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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