Congestive Heart FailurePhase 2STARBRITENCT00484770
STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure
A Phase 2 study testing Brain Natriuretic Peptide Levels -- Diagnostic testing and clinical assessment in people with Congestive Heart Failure, run by Duke University.
Trial summary
The primary hypothesis is that, in patients with advanced heart failure, an outpatient fluid management strategy guided by BNP levels and clinical targets will lead to fewer days hospitalized or dead over a 3-month period compared to an outpatient fluid management strategy using clinical targets alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Brain Natriuretic Peptide Levels -- Diagnostic testing and clinical assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Aug 2005
- Phase
- Phase 2
- 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
- Patients admitted with NYHA class III/IV symptoms of heart failure
- Left ventricular ejection fraction ≤35%
- Will have received at least one dose of intravenous diuretics during the current hospitalization
- Prior to discharge, has received heart failure education and has learned about daily weights, and fluid, sodium, and dietary restrictions
- Able to return for follow-up care at the Brigham and Women's Hospital Cardiomyopathy Clinic or the Duke Heart Failure Management Program
- Has regular access to a telephone
- ≥18 years of age
Who cannot join
- Moderate to severe valvular stenosis
- Admitted with acute coronary syndrome
- Creatinine >3.5
- Renal failure on hemodialysis
- Pregnant or lactating
About this study
Official title: Strategies for Tailoring Advanced Heart Failure Regimens in the Outpatient Setting: Brain Natriuretic Peptide Levels Versus the Clinical Congestion Score
The primary hypothesis is that, in patients with advanced heart failure, an outpatient fluid management strategy guided by BNP levels and clinical targets will lead to fewer days hospitalized or dead over a 3-month period compared to an outpatient fluid management strategy using clinical targets alone.
Read the detailed description
STARBRITE will test the hypothesis that a defined fluid management strategy, tailored to specific symptoms and physiological targets, will improve morbidity and mortality in the advanced heart failure population. Individual targets for each patient will be based on the outcome of the index hospitalization, during which therapy is adjusted to optimize clinical status, blood pressure, and renal function. Identifying a standard fluid management strategy may be an important way to limit the complications of diuretic therapy and the duration of hospitalization for these patients. In addition, a standard approach may provide objective criteria that can be used to systematically deliver care in many types of clinical settings.
In this study, patients will be randomized to two strategies of outpatient fluid management: 1) the Congestion Score Strategy and, 2) the BNP Strategy.
- Conditions
- Congestive Heart Failure
- Being tested
- Brain Natriuretic Peptide Levels -- Diagnostic testing, clinical assessment
- Keywords
- heart failure, brain natriuretic peptide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Natriuretic Peptide Levels -- Diagnostic testingDevice
clinical assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Congestion Score Strategy | Other | Not described Receives: Other: clinical assessment |
| BNP Strategy | Other | Not described Receives: Device: Brain Natriuretic Peptide Levels -- Diagnostic testing; Other: clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days neither hospitalized nor dead from the date of the first clinic visit to 90 days thereafter
Measured: 90 day follow up
Secondary outcomes (1)
1. Number of days not dead from the date of the first clinic visit to 90 days thereafter 2.Number of days not hospitalized from the date of the first clinic visit to 90 days thereafter
Measured: 90 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startFeb 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Investigators
- Monica R Shah, MD, Principal investigator, Duke University Medical Center/Washington Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484770
- Sponsor's protocol ID
- 4389
- Other IDs
- 0335132N
- Acronym
- STARBRITE
- Status last verified
- Jun 2007
- First submitted
- 7 Jun 2007
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shah, MR for the STARBRITE Investigators. STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients with Advanced Heart Failure. Abstract. Circulation Supplement, October 2005. Presented at the American Heart Association Meeting in November 2005.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Tailoring Advanced Heart Failure Regimens in the Outpatient Setting: Brain Natriuretic Peptide Levels Versus the Clinical Congestion Score
- ClinicalTrials.gov ID
- NCT00484770
- Acronym / sponsor ID
- STARBRITE / 4389
- Conditions
- Congestive Heart Failure
- Keywords
- heart failure, brain natriuretic peptide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Feb 2003
- Study completion
- Aug 2005 (actual)
- First posted
- 11 Jun 2007 (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 primary hypothesis is that, in patients with advanced heart failure, an outpatient fluid management strategy guided by BNP levels and clinical targets will lead to fewer days hospitalized or dead over a 3-month period compared to an outpatient fluid management strategy using clinical targets alone.
Detailed description
STARBRITE will test the hypothesis that a defined fluid management strategy, tailored to specific symptoms and physiological targets, will improve morbidity and mortality in the advanced heart failure population. Individual targets for each patient will be based on the outcome of the index hospitalization, during which therapy is adjusted to optimize clinical status, blood pressure, and renal function. Identifying a standard fluid management strategy may be an important way to limit the complications of diuretic therapy and the duration of hospitalization for these patients. In addition, a standard approach may provide objective criteria that can be used to systematically deliver care in many types of clinical settings.
In this study, patients will be randomized to two strategies of outpatient fluid management: 1) the Congestion Score Strategy and, 2) the BNP Strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congestion Score Strategy | Other | Other: clinical assessment |
| BNP Strategy | Other | Device: Brain Natriuretic Peptide Levels -- Diagnostic testing, Other: clinical assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients admitted with NYHA class III/IV symptoms of heart failure
- Left ventricular ejection fraction ≤35%
- Will have received at least one dose of intravenous diuretics during the current hospitalization
- Prior to discharge, has received heart failure education and has learned about daily weights, and fluid, sodium, and dietary restrictions
- Able to return for follow-up care at the Brigham and Women's Hospital Cardiomyopathy Clinic or the Duke Heart Failure Management Program
Key exclusion criteria (5 listed)
- Moderate to severe valvular stenosis
- Admitted with acute coronary syndrome
- Creatinine >3.5
- Renal failure on hemodialysis
- Pregnant or lactating
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 |
|---|---|---|
| Brain Natriuretic Peptide Levels -- Diagnostic testing | Device | BNP Strategy |
| clinical assessment | Other | BNP Strategy, Congestion Score Strategy |
Primary outcome
Number of days neither hospitalized nor dead from the date of the first clinic visit to 90 days thereafter
Time frame: 90 day follow up
1 secondary outcome
1. Number of days not dead from the date of the first clinic visit to 90 days thereafter 2.Number of days not hospitalized from the date of the first clinic visit to 90 days thereafter
Time frame: 90 day follow up
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 15 Nov 2023.
- Results publicationShah, MR for the STARBRITE Investigators. STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients with Advanced Heart Failure. Abstract. Circulation Supplement, October 2005. Presented at the American Heart Association Meeting in November 2005.
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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.
Monica R Shah, MD principal investigator
Duke University Medical Center/Washington Hospital Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brain Natriuretic Peptide Levels -- Diagnostic testing and clinical assessment in people with Congestive Heart Failure, run by Duke University.
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 7 inclusion and 5 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Number of days neither hospitalized nor dead from the date of the first clinic visit to 90 days thereafter (time frame: 90 day follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00484770, which also lists 1 linked publication.
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 15 Nov 2023.