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

Phase 4

Terminated

• Conditions: Heart Failure

• Registration Number: NCT00206856
• Lead Sponsor: Abbott RDx Cardiometabolic

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-26
• Last Update Posted: 2013-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 720

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (29)

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

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