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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00206856
• Other study ID #: 001
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 26, 2013
• Start date: July 2003
• Est. completion date: April 2006

Study information

• Verified date: July 2013
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 720
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Triage® B-Type Natriuretic Peptide (BNP) Test

Locations

Country	Name	City	State
United States	Medicor Cardiology	Bridgewater	New Jersey
United States	Buffalo Heart Group,	Buffalo	New York
United States	Carolinas Medical Center/Sanger Clinic	Charlotte	North Carolina
United States	Northwestern University Memorial	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Cleveland University Hospital	Cleveland	Ohio
United States	Denver Veterans Administration Hospital	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	Cardiology Associates of Fort Lauderdale	Fort Lauderdale	Florida
United States	Shands at the University of Florida	Gainsville	Florida
United States	Cardiovascular Medical Associates	Garden City	New York
United States	Baylor College of Medicine	Houston	Texas
United States	Midwest Heart Institute	Lombard	Illinois
United States	Minnesota Veterans Administration	Minneapolis	Minnesota
United States	Oschner Clinic	New Orleans	Louisiana
United States	Advocate Health	Oak Lawn	Illinois
United States	VNH Heart Center Research	Port Charlotte	Florida
United States	Latter Day Saints Hospital	Salt Lake City	Utah
United States	San Antonio VA Medical Center	San Antonio	Texas
United States	San Diego Veterans Administration Hospital	San Diego	California
United States	San Francisco Veterans Administration Hospital	San Francisco	California
United States	Scottsdale CardiovascularResearch	Scottsdale	Arizona
United States	Heart and Vascular Institute of Florida	St. Petersburg	Florida
United States	SUNY Upstate Medical University	Syracuse	New York
United States	William Beaumont Hospital-Troy	Troy	Michigan
United States	South Bay Cardiovascular Associates	West Islip	New York
United States	University Mass. Memorial Hospital	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined endpoint of mortality, unplanned clinic or hospital visits that require IV treatment for heart failure, and quality of life.
Secondary	All-cause re-hospitalization, Quality of Life, 6 minute walk distance, New York Heart Association class and BNP.