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

Study Overview
=================
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.

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

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: Brain Natriuretic Peptide Levels -- Diagnostic testing
* Other: clinical assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Congestion Score Strategy<br> | Other: clinical assessment<br> <br> |
| Other: BNP Strategy<br> | Device: Brain Natriuretic Peptide Levels -- Diagnostic testing<br> <br> Other: clinical assessment<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days neither hospitalized nor dead from the date of the first clinic visit to 90 days thereafter |  | 90 day follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, brain natriuretic peptide