DEVICE
STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure
Status
Completed
Phase
Phase 2
Enrollment
135
Locations
0
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
OTHER
clinical assessment
Timeline
From registration to results.
First posted
Jun 11, 2007
Study start
Feb 2003
Primary completion
Not reported
Study completion
Aug 2005
Results posted
Not reported
Registry updated
Nov 15, 2023
Outcomes
What the study measures.
Primary outcomes
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 outcomes
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients admitted with NYHA class III/IV symptoms of heart failure 2. Left ventricular ejection fraction ≤35% 3. Will have received at least one dose of intravenous diuretics during the current hospitalization 4. Prior to discharge, has received heart failure education and has learned about daily weights, and fluid, sodium, and dietary restrictions 5. Able to return for follow-up care at the Brigham and Women's Hospital Cardiomyopathy Clinic or the Duke Heart Failure Management Program 6. Has regular access to a telephone 7. ≥18 years of age Exclusion Criteria: 1. Moderate to severe valvular stenosis 2. Admitted with acute coronary syndrome 3. Creatinine \>3.5 4. Renal failure on hemodialysis 5. Pregnant or lactating
Study locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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