Heart FailureNCT00206843
Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)
A study testing Triage BNP Test in people with Heart Failure, run by Abbott RDx Cardiometabolic at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Triage BNP Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2004to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older Patient needs treatment for HF
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
New York Methodist Hospital
Brooklyn, New York, 11215
Chandler Regional Hospital
Chandler, Arizona, 85224
Detroit Receiving Hospital/Wayne State University
Detroit, Michigan, 48201
Sinai Grace Hospital/Wayne State
Detroit, Michigan, 48235
Duke University Hospital
Durham, North Carolina, 27710
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California, San Diego MedicalCenter
San Diego, California, 92103
Stony Brook University Hospital
Stony Brook, New York, 11794
Beaumont Hospital, Troy
Troy, Michigan, 48085
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Triage BNP Test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triage BNP TestDevice
| Study group | Role | What they receive |
|---|---|---|
| Results available | Experimental | Not described Receives: Device: Triage BNP Test |
| Results blinded | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionApr 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judd E Hollander, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206843
- Sponsor's protocol ID
- 005
- Status last verified
- Jul 2015
- First submitted
- 12 Sep 2005
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)
- ClinicalTrials.gov ID
- NCT00206843
- Acronym / sponsor ID
- 005
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Results available | Experimental | Device: Triage BNP Test |
| Results blinded | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 and older Patient needs treatment for HF
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triage BNP Test | Device | Results available |
Primary outcome
Length of hospital stay
Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day)
5 secondary outcomes
Discharge BNP
Change in BNP from enrollment to discharge (ΔBNP)
Ratio of ΔBNP/length of stay
Cost Effectiveness
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judd E Hollander, MD principal investigator
University of Pennsylvania
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triage BNP Test in people with Heart Failure, run by Abbott RDx Cardiometabolic at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.