STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
- 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 ]
- 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 |
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 |
Inclusion Criteria:
- Patients admitted with NYHA class III/IV symptoms of heart failure
- Left ventricular ejection fraction ≤35%
- Will have received at least one dose of intravenous diuretics during the current hospitalization
- Prior to discharge, has received heart failure education and has learned about daily weights, and fluid, sodium, and dietary restrictions
- Able to return for follow-up care at the Brigham and Women’s Hospital Cardiomyopathy Clinic or the Duke Heart Failure Management Program
- Has regular access to a telephone
- ≥18 years of age
Exclusion Criteria:
- Moderate to severe valvular stenosis
- Admitted with acute coronary syndrome
- Creatinine >3.5
- Renal failure on hemodialysis
- Pregnant or lactating
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00484770 History of Changes |
| Other Study ID Numbers: | 0335132N |
| Study First Received: | June 7, 2007 |
| Last Updated: | June 7, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
heart failure, brain natriuretic peptide |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Natriuretic Peptide, Brain Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013