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

NCT ID: NCT00206856

Last Updated: 2013-07-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2006-04-30

Brief Summary

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

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Interventions

Triage® B-Type Natriuretic Peptide (BNP) Test

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott RDx Cardiometabolic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James B Young, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Scottsdale CardiovascularResearch

Scottsdale, Arizona, United States

San Diego Veterans Administration Hospital

San Diego, California, United States

San Francisco Veterans Administration Hospital

San Francisco, California, United States

Denver Veterans Administration Hospital

Denver, Colorado, United States

Cardiology Associates of Fort Lauderdale

Fort Lauderdale, Florida, United States

Shands at the University of Florida

Gainsville, Florida, United States

VNH Heart Center Research

Port Charlotte, Florida, United States

Heart and Vascular Institute of Florida

St. Petersburg, Florida, United States

Northwestern University Memorial

Chicago, Illinois, United States

Midwest Heart Institute

Lombard, Illinois, United States

Advocate Health

Oak Lawn, Illinois, United States

Oschner Clinic

New Orleans, Louisiana, United States

University Mass. Memorial Hospital

Worcester, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

William Beaumont Hospital-Troy

Troy, Michigan, United States

Minnesota Veterans Administration

Minneapolis, Minnesota, United States

Medicor Cardiology

Bridgewater, New Jersey, United States

Buffalo Heart Group,

Buffalo, New York, United States

Cardiovascular Medical Associates

Garden City, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

South Bay Cardiovascular Associates

West Islip, New York, United States

Carolinas Medical Center/Sanger Clinic

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Cleveland University Hospital

Cleveland, Ohio, United States

Baylor College of Medicine

Houston, Texas, United States

San Antonio VA Medical Center

San Antonio, Texas, United States

Latter Day Saints Hospital

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id