Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)

Heart Failure Clinical Trial

Official title: Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)

Status Terminated

Clinical Trial Summary

To determine the clinical utility of using the Triage® BNP Test to guide therapy in outpatients with heart failure

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT00206856
• Study type: Interventional
• Source: Biosite
• Status: Terminated
• Phase: Phase 4
• Start date: July 2003
• Completion date: April 2006