Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)

July 26, 2013 updated by: Biosite
To determine the clinical utility of using the Triage® BNP Test to guide therapy in outpatients with heart failure

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The Triage® BNP Test has been cleared by the U.S. Food and Drug Administration as an aid in the diagnosis and assessment of severity of heart failure. In addition to numerous reports describing the diagnostic and prognostic utility of BNP, reports from various pilot studies have described decreases in BNP in association with various heart failure therapies. Other reports have described modest increases in BNP in association with digitalis and beta-receptor antagonism. The observation that the circulating BNP concentration decreases during heart failure therapy, coupled with the ability of BNP to be used as a prognostic tool and assess the severity of heart failure, it is hypothesized that using BNP measurements to guide heart failure therapy could have a significant impact on the care of heart failure patients. This hypothesis is supported by various reports of pilot studies that describe a significant benefit of administering therapy tailored to concentrations of BNP and related peptides. Patients that are discharged after a hospitalization for heart failure will be approached for study enrollment.This is a multi-center, single (patient)-blinded cluster-randomized study. Half of the sites will have BNP measurements available to guide therapy (experimental arm) and the other half of the sites will not have BNP measurements available (control arm). Blood (plasma) will be collected at each visit and appropriate forms completed. Patients will be asked to complete a Minnesota living with heart failure questionnaire and to do a 6-minute walk test. Patients will be followed for 12 months.

Study Type

Interventional

Enrollment

720

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Scottsdale CardiovascularResearch
    • California
      • San Diego, California, United States, 92161
        • San Diego Veterans Administration Hospital
      • San Francisco, California, United States, 94121-1545
        • San Francisco Veterans Administration Hospital
    • Colorado
      • Denver, Colorado, United States, 80220
        • Denver Veterans Administration Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Cardiology Associates of Fort Lauderdale
      • Gainsville, Florida, United States, 32610
        • Shands at the University of Florida
      • Port Charlotte, Florida, United States, 33952
        • VNH Heart Center Research
      • St. Petersburg, Florida, United States, 33701
        • Heart and Vascular Institute of Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Memorial
      • Lombard, Illinois, United States, 60148
        • Midwest Heart Institute
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Health
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Oschner Clinic
    • Massachusetts
      • Worcester, Massachusetts, United States, 06155
        • University Mass. Memorial Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital-Troy
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minnesota Veterans Administration
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Medicor Cardiology
    • New York
      • Buffalo, New York, United States, 14215
        • Buffalo Heart Group,
      • Garden City, New York, United States, 11530
        • Cardiovascular Medical Associates
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • West Islip, New York, United States, 11795
        • South Bay Cardiovascular Associates
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Sanger Clinic
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0542
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • Cleveland University Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 32610
        • San Antonio VA Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • Latter Day Saints Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age 18 or older Patient was hospitalized and treated for heart failure Patient is fully stabilized at discharge Able to give informed consent

Exclusion Criteria:

History of severe pulmonary disease Chronic O2 therapy for COPD Primary pulmonary hypertension History of renal disease requiring dialysis History of severe hepatic disease Patients using LVAD's Stroke, MI, PTCA, CABG or unstable angina within the past 1 month Bi-ventricular pacemaker placement within last 1 month History of severe aortic stenosis History of severe mitral stenosis History of constrictive pericarditis Patient has had a cardiac transplant Status 1 cardiac transplant candidates ICD or DRG assignment of non-Q wave MI within last 1 month Patient has cor pulmonale A re-hospitalization, death or an IV treatment for heart failure before the first post-discharge visit and/or15) Planned chronic IV treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Combined endpoint of mortality, unplanned clinic or hospital visits that require IV treatment for heart failure, and quality of life.

Secondary Outcome Measures

Outcome Measure
All-cause re-hospitalization, Quality of Life, 6 minute walk distance, New York Heart Association class and BNP.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosite

Investigators

  • Principal Investigator: James B Young, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

July 29, 2013

Last Update Submitted That Met QC Criteria

July 26, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Marta Eliza Miller Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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