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

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00484770
First received: June 7, 2007
Last updated: August 20, 2014
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure
Device: Brain Natriuretic Peptide Levels -- Diagnostic testing
Other: clinical assessment
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 135
Study Start Date: February 2003
Study Completion Date: August 2005
Arms Assigned Interventions
Congestion Score Strategy Other: clinical assessment
BNP Strategy Device: Brain Natriuretic Peptide Levels -- Diagnostic testing Other: clinical assessment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484770

Sponsors and Collaborators
Duke University
American Heart Association
Investigators
Principal Investigator: Monica R Shah, MD Duke University Medical Center/Washington Hospital Center
  More Information

Publications:
Shah, MR for the STARBRITE Investigators. STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients with Advanced Heart Failure. Abstract. Circulation Supplement, October 2005. Presented at the American Heart Association Meeting in November 2005.

ClinicalTrials.gov Identifier: NCT00484770     History of Changes
Other Study ID Numbers: 4389, 0335132N
Study First Received: June 7, 2007
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
heart failure, brain natriuretic peptide

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014