Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)
To determine the clinical utility of using the Triage® BNP Test to guide therapy in outpatients with heart failure
Device: Triage® B-Type Natriuretic Peptide (BNP) Test
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
|Official Title:||Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)|
- Combined endpoint of mortality, unplanned clinic or hospital visits that require IV treatment for heart failure, and quality of life.
- All-cause re-hospitalization, Quality of Life, 6 minute walk distance, New York Heart Association class and BNP.
|Study Start Date:||July 2003|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
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.
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|Principal Investigator:||James B Young, MD||The Cleveland Clinic|