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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271154

  Show 65 Study Locations
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
Ventricular Dysfunction, Left
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014