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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Triage® B-Type Natriuretic Peptide (BNP) Test
Sponsored by
Biosite
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scottsdale CardiovascularResearch
  • San Diego Veterans Administration Hospital
  • San Francisco Veterans Administration Hospital
  • Denver Veterans Administration Hospital
  • Cardiology Associates of Fort Lauderdale
  • Shands at the University of Florida
  • VNH Heart Center Research
  • Heart and Vascular Institute of Florida
  • Northwestern University Memorial
  • Midwest Heart Institute
  • Advocate Health
  • Oschner Clinic
  • University Mass. Memorial Hospital
  • Henry Ford Health System
  • William Beaumont Hospital-Troy
  • Minnesota Veterans Administration
  • Medicor Cardiology
  • Buffalo Heart Group,
  • Cardiovascular Medical Associates
  • SUNY Upstate Medical University
  • South Bay Cardiovascular Associates
  • Carolinas Medical Center/Sanger Clinic
  • Duke University
  • University of Cincinnati
  • Cleveland Clinic Foundation
  • Cleveland University Hospital
  • Baylor College of Medicine
  • San Antonio VA Medical Center
  • Latter Day Saints Hospital

Outcomes

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.

Full Information

First Posted
September 13, 2005
Last Updated
July 26, 2013
Sponsor
Biosite
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1. Study Identification

Unique Protocol Identification Number
NCT00206856
Brief Title
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
July 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosite

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
720 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Triage® B-Type Natriuretic Peptide (BNP) Test
Primary Outcome Measure Information:
Title
Combined endpoint of mortality, unplanned clinic or hospital visits that require IV treatment for heart failure, and quality of life.
Secondary Outcome Measure Information:
Title
All-cause re-hospitalization, Quality of Life, 6 minute walk distance, New York Heart Association class and BNP.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B Young, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scottsdale CardiovascularResearch
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
San Diego Veterans Administration Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
San Francisco Veterans Administration Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94121-1545
Country
United States
Facility Name
Denver Veterans Administration Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Cardiology Associates of Fort Lauderdale
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Shands at the University of Florida
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
VNH Heart Center Research
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Heart and Vascular Institute of Florida
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Northwestern University Memorial
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Midwest Heart Institute
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Advocate Health
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Oschner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University Mass. Memorial Hospital
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
06155
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
William Beaumont Hospital-Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Minnesota Veterans Administration
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Medicor Cardiology
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Buffalo Heart Group,
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Cardiovascular Medical Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
South Bay Cardiovascular Associates
City
West Islip
State/Province
New York
ZIP/Postal Code
11795
Country
United States
Facility Name
Carolinas Medical Center/Sanger Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0542
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland University Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Antonio VA Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
32610
Country
United States
Facility Name
Latter Day Saints Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States

12. IPD Sharing Statement

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

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