REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) - Full Text View

Sponsored by:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00271154

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 with CRT

MedlinePlus related topics: Heart Failure Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

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

Primary Outcome Measures:

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). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

An ECHO test will be used to assess whether there has been any changes in the size and pumping capability of the heart. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	683
Study Start Date:	September 2004
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Optimal medical therapy (CRT off)	Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator with CRT All patients will be implanted with a market-released Medtronic CRT device or CRT/ICD device.
2: Active Comparator biventricular pacing (CRT on) in conjunction with optimal medical therapy	Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator with CRT All patients will be implanted with a market-released Medtronic CRT device 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 (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

Show 65 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

More Information

Publications indexed to this study:

Linde C, Abraham WT, Gold MR, St John Sutton M, Ghio S, Daubert C; REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008 Dec 2;52(23):1834-43. Epub 2008 Nov 7.

Responsible Party:	Medtronic CRDM ( CRDM Core Clinical )
Study ID Numbers:	233
Study First Received:	December 21, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00271154
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Heart Failure
Implantable Cardioverter Defibrillator
Cardiac Resynchronization Therapy

Study placed in the following topic categories:

Ventricular Dysfunction
Heart Failure
Heart Diseases
Ventricular Dysfunction, Left

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009