STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure (STARBRITE)
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Brain Natriuretic Peptide Levels -- Diagnostic testing
clinical assessment
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring heart failure, brain natriuretic peptide
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Moderate to severe valvular stenosis
- Admitted with acute coronary syndrome
- Creatinine >3.5
- Renal failure on hemodialysis
- Pregnant or lactating
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Congestion Score Strategy
BNP Strategy
Arm Description
Outcomes
Primary Outcome Measures
Number of days neither hospitalized nor dead from the date of the first clinic visit to 90 days thereafter
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00484770
First Posted
June 7, 2007
Last Updated
August 20, 2014
Sponsor
Duke University
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT00484770
Brief Title
STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure
Acronym
STARBRITE
Official Title
Strategies for Tailoring Advanced Heart Failure Regimens in the Outpatient Setting: Brain Natriuretic Peptide Levels Versus the Clinical Congestion Score
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Duke University
Collaborators
American Heart Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
heart failure, brain natriuretic peptide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Congestion Score Strategy
Arm Type
Other
Arm Title
BNP Strategy
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Brain Natriuretic Peptide Levels -- Diagnostic testing
Intervention Type
Other
Intervention Name(s)
clinical assessment
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Moderate to severe valvular stenosis
Admitted with acute coronary syndrome
Creatinine >3.5
Renal failure on hemodialysis
Pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica R Shah, MD
Organizational Affiliation
Duke University Medical Center/Washington Hospital Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Learn more about this trial
STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure
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