Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)
NCT ID: NCT00354159
Last Updated: 2012-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
442 participants
INTERVENTIONAL
2006-04-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Arm
Physicians have access to device-based hemodynamic monitor information to guide patient management
Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)
Surgical implantation of hemodynamic device (IHM), or IHM/ICD, and intracardiac leads.
Control Arm
Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)
Surgical implantation of hemodynamic device (IHM), or IHM/ICD, and intracardiac leads.
Interventions
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Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)
Surgical implantation of hemodynamic device (IHM), or IHM/ICD, and intracardiac leads.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has appropriate medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and beta blocker) for at least three months prior to the baseline evaluation.
* Subject has been on stable medications maximized to the subject's tolerance of ACE or ARB and beta blockers as determined by the study investigator for at least 30 days prior to baseline evaluation. (Stable is defined as no more than a 100% increase or a 50% decrease in dose.) If a subject is intolerant of ACE, ARB or beta blockers documented evidence must be available.
* Subject has had at least one heart failure-related hospitalization or at least one heart failure-related emergency department or urgent care visit necessitating heart failure-related intravenous therapy (e.g. diuretic administration) within 12 months prior to the baseline evaluation
* To be considered for Chronicle ICD: Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
1. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.
2. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.
Exclusion Criteria
* Subjects with severe renal dysfunction.
* Subjects with severe non-cardiac condition limiting 12-month survival.
* Subjects in concurrent studies that may confound the results.
(3)Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
(4)Stage D refractory heart failure: Patients who have marked symptoms at rest despite maximal medical therapy (e.g., those who are recurrently hospitalized or cannot be safely discharged from the hospital without specialized interventions)
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Phillip Adamson, MD
Role: STUDY_CHAIR
Oklahoma Heart Hospital
Michael Gold, MD
Role: STUDY_CHAIR
Medical University of South Carolina
Locations
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University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Scripps Green Hospital
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Long Beach Memorial
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Doctors Medical Center Modesto
Modesto, California, United States
Yale University, School of Medicine
New Haven, Connecticut, United States
Christiana Care Hospital
Newark, Delaware, United States
University of FL Shands
Gainesville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Crawford Long/Emory University Hospitals
Atlanta, Georgia, United States
Midwest Heart Foundation
Lombard, Illinois, United States
Genesis Hospital Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
St Joseph Mercy Hospital
Ann Arbor, Michigan, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mercy Hospital Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Mid America Heart Institute/St. Lukes
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Mt Sinai Medical Center
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Hospital Mid Carolinas Cardiology
Charlotte, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Lehigh Valley Heart Specialists
Allentown, Pennsylvania, United States
Lancaster Heart & Stroke Foundation
Lancaster, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Spartanburg Regional
Spartanburg, South Carolina, United States
Baptist Hospital
Nashville, Tennessee, United States
St Thomas
Nashville, Tennessee, United States
Baylor Research Institute
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States
Countries
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References
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Reiter MJ, Stromberg KD, Whitman TA, Adamson PB, Benditt DG, Gold MR. Influence of intracardiac pressure on spontaneous ventricular arrhythmias in patients with systolic heart failure: insights from the REDUCEhf trial. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):272-8. doi: 10.1161/CIRCEP.113.000223. Epub 2013 Mar 20.
Adamson PB, Conti JB, Smith AL, Abraham WT, Aaron MF, Aranda JM Jr, Baker J, Bourge RC, Warner-Stevenson L, Sparks B. Reducing events in patients with chronic heart failure (REDUCEhf ) study design: continuous hemodynamic monitoring with an implantable defibrillator. Clin Cardiol. 2007 Nov;30(11):567-75. doi: 10.1002/clc.20250.
Other Identifiers
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103
Identifier Type: -
Identifier Source: org_study_id