REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

January 26, 2012 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

684

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Alabama
      • Huntsville, Alabama, United States
    • Alaska
      • Anchorage, Alaska, United States
    • California
      • Redwood City, California, United States
      • San Diego, California, United States
    • Florida
      • Atlantis, Florida, United States
      • Jacksonville, Florida, United States
    • Illinois
      • Springfield, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Burlington, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Saginaw, Michigan, United States
    • Minnesota
      • Coon Rapids, Minnesota, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New York
      • East Syracuse, New York, United States
      • Manhasset, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Marion, Ohio, United States
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
      • Hershey, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Kingsport, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Houston, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Worsened for Clinical Composite Response
Time Frame: 12 Months
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.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)
Time Frame: Baseline to 12 months
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.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: Cecilia Linde, MD, PhD, Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 28, 2005

First Posted (Estimate)

December 30, 2005

Study Record Updates

Last Update Posted (Estimate)

January 30, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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