REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00271154
First received: December 21, 2005
Last updated: January 26, 2012
Last verified: January 2012
Results First Received: December 24, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Heart Failure
Intervention: Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT

  Participant Flow
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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
    CRT OFF     CRT ON  
STARTED     191     419  
COMPLETED     191     419  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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
Total Total of all reporting groups

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: CRDM Core Clinical
Organization: Medtronic CRDM
phone: 800-328-2518
e-mail: medtroniccrmtrials@medtronic.com


Publications of Results:
Publications automatically indexed to this study:


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