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

Sponsor:	Medtronic Cardiac Rhythm Disease Management
Information provided by (Responsible Party):	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 (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:

MedlinePlus related topics: Heart Failure Pacemakers and Implantable Defibrillators

U.S. FDA Resources

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

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:

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.

Linde C, Gold M, Abraham WT, Daubert JC; REVERSE Study Group. Baseline characteristics of patients randomized in The Resynchronization Reverses Remodeling In Systolic Left Ventricular Dysfunction (REVERSE) study. Congest Heart Fail. 2008 Mar-Apr;14(2):66-74.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gold MR, Linde C, Abraham WT, Gardiwal A, Daubert JC. The impact of cardiac resynchronization therapy on the incidence of ventricular arrhythmias in mild heart failure. Heart Rhythm. 2011 May;8(5):679-84. Epub 2010 Dec 23.

Linde C, Abraham WT, Gold MR, Daubert C; REVERSE Study Group. Cardiac resynchronization therapy in asymptomatic or mildly symptomatic heart failure patients in relation to etiology: results from the REVERSE (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction) study. J Am Coll Cardiol. 2010 Nov 23;56(22):1826-31.

Linde C, Daubert C. Cardiac resynchronization therapy in patients with New York Heart Association class I and II heart failure: an approach to 2010. Circulation. 2010 Sep 7;122(10):1037-43. No abstract available.

St John Sutton M, Ghio S, Plappert T, Tavazzi L, Scelsi L, Daubert C, Abraham WT, Gold MR, Hassager C, Herre JM, Linde C; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) Study Group. Cardiac resynchronization induces major structural and functional reverse remodeling in patients with New York Heart Association class I/II heart failure. Circulation. 2009 Nov 10;120(19):1858-65. Epub 2009 Oct 26.

Daubert C, Gold MR, Abraham WT, Ghio S, Hassager C, Goode G, Szili-Török T, Linde C; REVERSE Study Group. Prevention of disease progression by cardiac resynchronization therapy in patients with asymptomatic or mildly symptomatic left ventricular dysfunction: insights from the european cohort of the reverse (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial. J Am Coll Cardiol. 2009 Nov 10;54(20):1837-46. Epub 2009 Oct 1.

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, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012