REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

This study is ongoing, but not recruiting participants.

Study NCT00271154 Information provided by Medtronic Cardiac Rhythm Disease Management

First Received: December 21, 2005 Last Updated: March 26, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Condition:	Heart Failure
Intervention:	Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled from September 2004 through September 2006 at 73 sites located in the United States, Canada, and Europe.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 684 patients were enrolled in the study. Of these, 642 patients were attempted for cardiac resynchronization therapy (CRT) device implant. 21 were unsuccessful, leaving 621 patients successfully implanted with a CRT device. Of these 621 patients, 610 were randomized.

Reporting Groups

	Description
CRT OFF	Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
CRT ON	Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
CRT OFF	Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
CRT ON	Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy

Baseline Measures

	CRT OFF	CRT ON	Total
Number of Participants [units: participants]	191	419	610
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	108	229	337
>=65 years	83	190	273
Age [units: years] Mean ± Standard Deviation	61.8 ± 11.6	62.9 ± 10.6	62.5 ± 11.0
Gender [units: participants]
Female	39	92	131
Male	152	327	479
Region of Enrollment [units: participants]
United States	108	235	343
Spain	9	18	27
Ireland	1	4	5
Austria	2	4	6
United Kingdom	6	9	15
Italy	5	12	17
France	15	34	49
Czech Republic	0	1	1
Hungary	6	13	19
Canada	1	4	5
Belgium	1	3	4
Denmark	19	46	65
Germany	6	11	17
Norway	3	4	7
Sweden	7	17	24
Netherlands	2	4	6

Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2