Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)
This study has been terminated.
Sponsored by: Biosite
Information provided by: Biosite
ClinicalTrials.gov Identifier: NCT00206856
  Purpose

To determine the clinical utility of using the Triage® BNP Test to guide therapy in outpatients with heart failure


Condition Intervention Phase
Heart Failure
Device: Triage® B-Type Natriuretic Peptide (BNP) Test
Phase IV

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title: Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)

Further study details as provided by Biosite:

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

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

Estimated Enrollment: 720
Study Start Date: July 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206856

  Show 29 Study Locations
Sponsors and Collaborators
Biosite
Investigators
Principal Investigator: James B Young, MD The Cleveland Clinic
  More Information

Study ID Numbers: 001
Study First Received: September 13, 2005
Last Updated: April 26, 2006
ClinicalTrials.gov Identifier: NCT00206856  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009