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

NCT ID: NCT00484770

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2005-08-31

Brief 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.

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Congestion Score Strategy

Group Type: OTHER

clinical assessment

Intervention Type: OTHER

BNP Strategy

Group Type: OTHER

Brain Natriuretic Peptide Levels -- Diagnostic testing

Intervention Type: DEVICE

clinical assessment

Intervention Type: OTHER

Interventions

Brain Natriuretic Peptide Levels -- Diagnostic testing

Intervention Type: DEVICE

clinical assessment

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Principal Investigators

Monica R Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center/Washington Hospital Center

References

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.

Reference Type: RESULT

Other Identifiers

0335132N

Identifier Type: -

Identifier Source: secondary_id

4389

Identifier Type: -

Identifier Source: org_study_id