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

December 21, 2005
January 26, 2012
September 2004
October 2007   (final data collection date for primary outcome measure)
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.
Measures used to assess the effect pacing therapy on heart failure status include: a physical exam, subject questionnaires, 6-minute walk test, electrocardiogram (ECG), and echocardiogram (ECHO).
Complete list of historical versions of study NCT00271154 on ClinicalTrials.gov Archive Site
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.
An ECHO test will be used to assess whether there has been any changes in the size and pumping capability of the heart.
Not Provided
Not Provided
 
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Heart Failure
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.
  • Placebo Comparator: CRT OFF
    Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
    Intervention: Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
  • Active Comparator: CRT ON
    Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
    Intervention: Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
684
November 2011
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   United States,   United Kingdom,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   Ireland,   Italy,   Norway,   Spain,   Sweden
 
NCT00271154
233
Yes
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Principal Investigator: Cecilia Linde, MD, PhD Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
Medtronic Cardiac Rhythm Disease Management
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP