REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00271154
First received: December 21, 2005
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. The purpose of the REVERSE clinical trial is to determine whether pacing in both the left and right ventricles using Cardiac Resynchronization Therapy (CRT) can help slow the progression of heart failure in people who have mild or previous symptoms and poor heart pumping function. This kind of therapy has previously been shown to reduce symptoms and improve exercise capacity in people with more advanced forms of heart failure.


Condition Intervention
Heart Failure
Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Percentage of Patients Worsened for Clinical Composite Response [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse HF symptoms compared to before CRT implant.


Secondary Outcome Measures:
  • Change in Left Ventricular End Systolic Volume, Indexed (LVESVi) [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    The change is LVESVi measured at 12 months minus LVESVi measured at baseline. The 12-month echocardiographic measurements were made with CRT programmed off, irespective of the treatment assignment. In CRT ON patients these measurements were recorded after a 10 minute washout period. Two core laboratories performed all echo measurements.


Enrollment: 684
Study Start Date: September 2004
Study Completion Date: November 2011
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: CRT OFF
Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
All randomized patients will be implanted with a market-released Medtronic CRT or CRT/ICD device.
Active Comparator: CRT ON
Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
All randomized patients will be implanted with a market-released Medtronic CRT or CRT/ICD device.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with previously symptomatic heart failure but no current symptoms (New York Heart Association (NYHA) Class I, Stage C) or subjects with mild heart failure that only sometimes interferes with daily activities (NYHA Class II)
  • Subjects with a QRS of 120 ms or more (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels/conducts through the ventricles. A wide QRS (120 ms or more) suggests that there is a conduction problem (or block) in the ventricles).
  • Subjects with a left ventricular ejection fraction less than or equal to 40%. (The left ventricular ejection fraction (LVEF) is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the LVEF the more blood the ventricle is pumping.)
  • Subjects with a left ventricular end diastolic dimension (LVEDD) greater than or equal to 55. (The left ventricular end diastolic dimension (LVEDD) is a measurement of heart size taken during an echocardiogram that is one indication of the health of the left ventricle.)

Exclusion Criteria:

  • Subjects who are pacemaker dependent (heart would not beat without the help of an implanted device to pace it).
  • Subjects with heart failure that severely limits daily activities (NYHA Class III) or subjects with severe heart failure with symptoms while resting (NYHA Class IV).
  • Subjects hospitalized due to heart failure within past 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271154

  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States
United States, Alaska
Anchorage, Alaska, United States
United States, California
Redwood City, California, United States
San Diego, California, United States
United States, Florida
Atlantis, Florida, United States
Jacksonville, Florida, United States
United States, Illinois
Springfield, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Iowa
Des Moines, Iowa, United States
United States, Massachusetts
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Saginaw, Michigan, United States
United States, Minnesota
Coon Rapids, Minnesota, United States
United States, Mississippi
Tupelo, Mississippi, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, New York
East Syracuse, New York, United States
Manhasset, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Marion, Ohio, United States
United States, Pennsylvania
Doylestown, Pennsylvania, United States
Hershey, Pennsylvania, United States
West Reading, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Germantown, Tennessee, United States
Kingsport, Tennessee, United States
United States, Texas
Austin, Texas, United States
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Wisconsin
Madison, Wisconsin, United States
Austria
St. Polten, Austria
Weiner Neustadt, Austria
Belgium
Leuven, Belgium
Canada, Ontario
Kingston, Ontario, Canada
Czech Republic
Brno, Czech Republic
Olomouc, Czech Republic
Denmark
Aalborg, Denmark
Aarhus, Denmark
Copenhagen, Denmark
Odense, Denmark
France
Lyon, France
Marseille, France
Montpellier, France
Nantes, France
Rennes, France
Germany
Bochum, Germany
Hamburg, Germany
Hannover, Germany
Hungary
Budapest, Hungary
Szeged, Hungary
Ireland
Dublin, Ireland
Italy
Busto Arsizio, Italy
Florence, Italy
Milano, Italy
Rome, Italy
Norway
Kristiansand, Norway
Spain
Madrid, Spain
Valencia, Spain
Sweden
Linkoping, Sweden
Stockholm, Sweden
United Kingdom
Blackpool, United Kingdom
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Cecilia Linde, MD, PhD Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00271154     History of Changes
Other Study ID Numbers: 233
Study First Received: December 21, 2005
Results First Received: December 24, 2008
Last Updated: January 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Heart Failure
Implantable Cardioverter Defibrillator
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014