REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00271154
• Date of registration: 21/12/2005
• Primary sponsor: Medtronic Cardiac Rhythm Disease Management
• Public title: REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
• Scientific title: REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
• Date of first enrolment: September 2004
• Target sample size: 684
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00271154
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Norway, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Cecilia Linde, MD, PhD
• Affiliation: Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT

Primary Outcome(s)

Percentage of Patients Worsened for Clinical Composite Response [Time Frame: 12 Months]

Secondary Outcome(s)

Change in Left Ventricular End Systolic Volume, Indexed (LVESVi) [Time Frame: Baseline to 12 months]

Secondary ID(s)

233

Source(s) of Monetary Support

Please refer to primary and secondary sponsors