STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure
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.
Congestive Heart Failure
Device: Brain Natriuretic Peptide Levels -- Diagnostic testing
Other: clinical assessment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Strategies for Tailoring Advanced Heart Failure Regimens in the Outpatient Setting: Brain Natriuretic Peptide Levels Versus the Clinical Congestion Score|
- 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. 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 ]
|Study Start Date:||February 2003|
|Study Completion Date:||August 2005|
|Congestion Score Strategy||Other: clinical assessment|
|BNP Strategy||Device: Brain Natriuretic Peptide Levels -- Diagnostic testing Other: clinical assessment|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484770
|Principal Investigator:||Monica R Shah, MD||Duke University Medical Center/Washington Hospital Center|