Heart FailurePhase 4NCT00206856
Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)
A Phase 4 study testing Triage® B-Type Natriuretic Peptide (BNP) Test in people with Heart Failure, run by Abbott RDx Cardiometabolic at 29 sites in United States.
Trial summary
To determine the clinical utility of using the Triage® BNP Test to guide therapy in outpatients with heart failure 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® B-Type Natriuretic Peptide (BNP) Test
- Type of treatment
- Medical device
- How many people
- 720 participants
- Where
- 29 sitesUnited States
- Study dates
- Jul 2003to Apr 2006
- Phase
- Phase 4
- 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 or older Patient was hospitalized and treated for heart failure Patient is fully stabilized at discharge Able to give informed consent
Who cannot join
- History of severe pulmonary disease Chronic O2 therapy for COPD Primary pulmonary hypertension History of renal disease requiring dialysis History of severe hepatic disease Patients using LVAD's Stroke, MI, PTCA, CABG or unstable angina within the past 1 month Bi-ventricular pacemaker placement within last 1 month History of severe aortic stenosis History of severe mitral stenosis History of constrictive pericarditis Patient has had a cardiac transplant Status 1 cardiac transplant candidates ICD or DRG assignment of non-Q wave MI within last 1 month Patient has cor pulmonale A re-hospitalization, death or an IV treatment for heart failure before the first post-discharge visit and/or15) Planned chronic IV treatment.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Medicor Cardiology
Bridgewater, New Jersey, 08807
Buffalo Heart Group,
Buffalo, New York, 14215
Carolinas Medical Center/Sanger Clinic
Charlotte, North Carolina, 28203
Northwestern University Memorial
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45267-0542
Cleveland Clinic Foundation
Cleveland, Ohio, 44106
Cleveland University Hospital
Cleveland, Ohio, 44106
Denver Veterans Administration Hospital
Denver, Colorado, 80220
Henry Ford Health System
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
Cardiology Associates of Fort Lauderdale
Fort Lauderdale, Florida, 33308
Shands at the University of Florida
Gainsville, Florida, 32610
Cardiovascular Medical Associates
Garden City, New York, 11530
Baylor College of Medicine
Houston, Texas, 77030
Midwest Heart Institute
Lombard, Illinois, 60148
Minnesota Veterans Administration
Minneapolis, Minnesota, 55417
Oschner Clinic
New Orleans, Louisiana, 70121
Advocate Health
Oak Lawn, Illinois, 60453
VNH Heart Center Research
Port Charlotte, Florida, 33952
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
San Antonio VA Medical Center
San Antonio, Texas, 32610
San Diego Veterans Administration Hospital
San Diego, California, 92161
San Francisco Veterans Administration Hospital
San Francisco, California, 94121-1545
Scottsdale CardiovascularResearch
Scottsdale, Arizona, 85251
Heart and Vascular Institute of Florida
St. Petersburg, Florida, 33701
SUNY Upstate Medical University
Syracuse, New York, 13210
William Beaumont Hospital-Troy
Troy, Michigan, 48085
South Bay Cardiovascular Associates
West Islip, New York, 11795
University Mass. Memorial Hospital
Worcester, Massachusetts, 06155
About this study
To determine the clinical utility of using the Triage® BNP Test to guide therapy in outpatients with heart failure
Read the detailed description
The Triage® BNP Test has been cleared by the U.S. Food and Drug Administration as an aid in the diagnosis and assessment of severity of heart failure. In addition to numerous reports describing the diagnostic and prognostic utility of BNP, reports from various pilot studies have described decreases in BNP in association with various heart failure therapies. Other reports have described modest increases in BNP in association with digitalis and beta-receptor antagonism. The observation that the circulating BNP concentration decreases during heart failure therapy, coupled with the ability of BNP to be used as a prognostic tool and assess the severity of heart failure, it is hypothesized that using BNP measurements to guide heart failure therapy could have a significant impact on the care of heart failure patients. This hypothesis is supported by various reports of pilot studies that describe a significant benefit of administering therapy tailored to concentrations of BNP and related peptides. Patients that are discharged after a hospitalization for heart failure will be approached for study enrollment.This is a multi-center, single (patient)-blinded cluster-randomized study. Half of the sites will have BNP measurements available to guide therapy (experimental arm) and the other half of the sites will not have BNP measurements available (control arm). Blood (plasma) will be collected at each visit and appropriate forms completed. Patients will be asked to complete a Minnesota living with heart failure questionnaire and to do a 6-minute walk test. Patients will be followed for 12 months.
- Conditions
- Heart Failure
- Being tested
- Triage® B-Type Natriuretic Peptide (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® B-Type Natriuretic Peptide (BNP) TestDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint of mortality, unplanned clinic or hospital visits that require IV treatment for heart failure, and quality of life.
Secondary outcomes (1)
All-cause re-hospitalization, Quality of Life, 6 minute walk distance, New York Heart Association class and BNP.
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 startJul 2003
- Primary completionApr 2006
- Study completionApr 2006
Why it stopped: Slow enrollment
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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 720 participants
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James B Young, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206856
- Sponsor's protocol ID
- 001
- Status last verified
- Jul 2013
- First submitted
- 13 Sep 2005
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)
- ClinicalTrials.gov ID
- NCT00206856
- Acronym / sponsor ID
- 001
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 720 participants
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (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.
To determine the clinical utility of using the Triage® BNP Test to guide therapy in outpatients with heart failure
Detailed description
The Triage® BNP Test has been cleared by the U.S. Food and Drug Administration as an aid in the diagnosis and assessment of severity of heart failure. In addition to numerous reports describing the diagnostic and prognostic utility of BNP, reports from various pilot studies have described decreases in BNP in association with various heart failure therapies. Other reports have described modest increases in BNP in association with digitalis and beta-receptor antagonism. The observation that the circulating BNP concentration decreases during heart failure therapy, coupled with the ability of BNP to be used as a prognostic tool and assess the severity of heart failure, it is hypothesized that using BNP measurements to guide heart failure therapy could have a significant impact on the care of heart failure patients. This hypothesis is supported by various reports of pilot studies that describe a significant benefit of administering therapy tailored to concentrations of BNP and related peptides. Patients that are discharged after a hospitalization for heart failure will be approached for study enrollment.This is a multi-center, single (patient)-blinded cluster-randomized study. Half of the sites will have BNP measurements available to guide therapy (experimental arm) and the other half of the sites will not have BNP measurements available (control arm). Blood (plasma) will be collected at each visit and appropriate forms completed. Patients will be asked to complete a Minnesota living with heart failure questionnaire and to do a 6-minute walk test. Patients will be followed for 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
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 or older Patient was hospitalized and treated for heart failure Patient is fully stabilized at discharge Able to give informed consent
Key exclusion criteria (1 listed)
- History of severe pulmonary disease Chronic O2 therapy for COPD Primary pulmonary hypertension History of renal disease requiring dialysis History of severe hepatic disease Patients using LVAD's Stroke, MI, PTCA, CABG or unstable angina within the past 1 month Bi-ventricular pacemaker placement within last 1 month History of severe aortic stenosis History of severe mitral stenosis History of constrictive pericarditis Patient has had a cardiac transplant Status 1 cardiac transplant candidates ICD or DRG assignment of non-Q wave MI within last 1 month Patient has cor pulmonale A re-hospitalization, death or an IV treatment for heart failure before the first post-discharge visit and/or15) Planned chronic IV treatment.
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® B-Type Natriuretic Peptide (BNP) Test | Device | – |
Primary outcome
Combined endpoint of mortality, unplanned clinic or hospital visits that require IV treatment for heart failure, and quality of life.
1 secondary outcome
All-cause re-hospitalization, Quality of Life, 6 minute walk distance, New York Heart Association class and BNP.
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
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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.
James B Young, MD principal investigator
The Cleveland Clinic
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triage® B-Type Natriuretic Peptide (BNP) Test in people with Heart Failure, run by Abbott RDx Cardiometabolic at 29 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: stopped early, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
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?
Combined endpoint of mortality, unplanned clinic or hospital visits that require IV treatment for heart failure, and quality of life.. 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 29 Jul 2013.