REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

Heart Failure Clinical Trial

Official title:

REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271154
• Other study ID #: 233
• Status: Completed
• Phase: N/A
• First received: December 21, 2005
• Last updated: January 26, 2012
• Start date: September 2004
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. completion date: November 2011
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

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

References & Publications (2)

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 pati — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Worsened for Clinical Composite Response	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.	12 Months	No
Secondary	Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)	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.	Baseline to 12 months	No