NCT00484770

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2007

Completed
Last Updated

November 15, 2023

Status Verified

June 1, 2007

First QC Date

June 7, 2007

Last Update Submit

November 14, 2023

Conditions

Congestive Heart Failure

Keywords

heart failure, brain natriuretic peptide

Outcome Measures

Primary Outcomes (1)

  • Number of days neither hospitalized nor dead from the date of the first clinic visit to 90 days thereafter

    90 day follow up

Secondary Outcomes (1)

  • 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

Study Arms (2)

Congestion Score Strategy

OTHER
Other: clinical assessment

BNP Strategy

OTHER
Device: Brain Natriuretic Peptide Levels -- Diagnostic testingOther: clinical assessment

Interventions

Brain Natriuretic Peptide Levels -- Diagnostic testingDEVICE
BNP Strategy
clinical assessmentOTHER
BNP StrategyCongestion Score Strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Moderate to severe valvular stenosis
  • Admitted with acute coronary syndrome
  • Creatinine \>3.5
  • Renal failure on hemodialysis
  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 2005.

    RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Monica R Shah, MD

    Duke University Medical Center/Washington Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2007

First Posted

June 11, 2007

Study Start

February 1, 2003

Study Completion

August 1, 2005

Last Updated

November 15, 2023

Record last verified: 2007-06