STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure — STARBRITE  

Congestive Heart Failure Clinical Trial

Official title: Strategies for Tailoring Advanced Heart Failure Regimens in the Outpatient Setting: Brain Natriuretic Peptide Levels Versus the Clinical Congestion Score

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

• NCT number: NCT00484770
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 2
• Start date: February 2003
• Completion date: August 2005