Clinical trial NCT00206856: Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)
Official title: Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Combined endpoint of mortality, unplanned clinic or hospital visits that require IV treatment for heart failure, and quality of life.
Secondary outcomes:
measure: All-cause re-hospitalization, Quality of Life, 6 minute walk distance, New York Heart Association class and BNP.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale CardiovascularResearch
state: Arizona
city: San Diego
country: United States
facility: San Diego Veterans Administration Hospital
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Hospital
state: California
city: Denver
country: United States
facility: Denver Veterans Administration Hospital
state: Colorado
city: Fort Lauderdale
country: United States
facility: Cardiology Associates of Fort Lauderdale
state: Florida
city: Gainsville
country: United States
facility: Shands at the University of Florida
state: Florida
city: Port Charlotte
country: United States
facility: VNH Heart Center Research
state: Florida
city: St. Petersburg
country: United States
facility: Heart and Vascular Institute of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern University Memorial
state: Illinois
city: Lombard
country: United States
facility: Midwest Heart Institute
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Health
state: Illinois
city: New Orleans
country: United States
facility: Oschner Clinic
state: Louisiana
city: Worcester
country: United States
facility: University Mass. Memorial Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital-Troy
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Veterans Administration
state: Minnesota
city: Bridgewater
country: United States
facility: Medicor Cardiology
state: New Jersey
city: Buffalo
country: United States
facility: Buffalo Heart Group,
state: New York
city: Garden City
country: United States
facility: Cardiovascular Medical Associates
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: West Islip
country: United States
facility: South Bay Cardiovascular Associates
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center/Sanger Clinic
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: Cleveland University Hospital
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: San Antonio VA Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Latter Day Saints Hospital
state: Utah
Study officials:
affiliation: The Cleveland Clinic
name: James B Young, MD
role: PRINCIPAL_INVESTIGATOR
References: