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

Congestive Heart Failure Clinical Trial

— STARBRITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484770
• Other study ID #: 4389
• Secondary ID: 0335132N
• Status: Completed
• Phase: Phase 2
• Start date: February 2003
• Est. completion date: August 2005

Study information

• Verified date: June 2007
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Brain Natriuretic Peptide Levels -- Diagnostic testing

Other:
• clinical assessment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	American Heart Association

References & Publications (1)

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 20

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days neither hospitalized nor dead from the date of the first clinic visit to 90 days thereafter		90 day follow up
Secondary	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		90 day follow up