Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00354159
First received: July 19, 2006
Last updated: August 7, 2012
Last verified: August 2012
Results First Received: January 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Heart Failure
Intervention: Device: Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)

  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
Recruitment began on April 28, 2006 and ended on January 14, 2011. All subjects were exited from the study on January 14, 2011. Fifty-three US clinical centers participated in the REDUCEhf study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled subjects were required to have a successful implant of the Chronicle® device prior to randomization. 407 subjects had an attempted implant of the Chronicle® ICD (Implantable Cardioverter Defibrillator) (406) or Chronicle IHM (Implantable Hemodynamic Monitor) (1 subject). Of these 407 subjects, 400 were randomized.

Reporting Groups
  Description
Treatment Arm Physicians have access to device-based hemodynamic monitor information to guide patient management
Control Arm Physicians do not have access to device-based hemodynamic monitor information to guide patient management

Participant Flow for 2 periods

Period 1:   Randomized Study Period
    Treatment Arm     Control Arm  
STARTED     202     198  
COMPLETED     180     176  
NOT COMPLETED     22     22  
Withdrawal by Subject                 5                 3  
Physician Decision                 6                 10  
Lost to Follow-up                 4                 0  
Death                 7                 9  

Period 2:   Long-term Follow-up
    Treatment Arm     Control Arm  
STARTED     180 [1]   176 [1]
COMPLETED     0 [2]   0 [2]
NOT COMPLETED     180     176  
Withdrawal by Subject                 9                 9  
Physician Decision                 127                 122  
Lost to Follow-up                 1                 0  
Death                 14                 11  
Study Closed                 29                 34  
[1] Number entering post 12-month non-randomized long-term follow-up period
[2] All subjects were exited at the time of study closure



  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.
No text entered.

Reporting Groups
  Description
Treatment Arm Physicians have access to device-based hemodynamic monitor information to guide patient management
Control Arm Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Total Total of all reporting groups

Baseline Measures
    Treatment Arm     Control Arm     Total  
Number of Participants  
[units: participants]
  202     198     400  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     151     144     295  
>=65 years     51     54     105  
Age  
[units: years]
Mean ± Standard Deviation
  54.8  ± 14.7     54.7  ± 14.8     54.7  ± 14.7  
Gender  
[units: participants]
     
Female     61     65     126  
Male     141     133     274  
Region of Enrollment  
[units: participants]
     
United States     202     198     400  
NYHA (New York Heart Association) Classification [1]
[units: participants]
     
NYHA Class II     107     90     197  
NYHA Class III     95     108     203  
[1]

Class II and Class III NYHA classification

Class II Subjects with cardiac disease resulting in slight limitation of physical activity.They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity.They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.




  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.   [ Time Frame: Within 6 months post-implant ]

2.  Primary:   Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant   [ Time Frame: 6 months post implant ]

3.  Primary:   Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group   [ Time Frame: 12 months post-implant ]

4.  Secondary:   Cumulative Days in the Hospital for Heart Failure   [ Time Frame: 12 months post-implant ]

5.  Secondary:   Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group   [ Time Frame: 12 months post-implant ]

6.  Secondary:   Freedom From All Cause Death or Heart Failure Hospitalization   [ Time Frame: 12 months post-implant ]

7.  Secondary:   Relative Risk of All-cause Events   [ Time Frame: 12 months post-implant ]

8.  Secondary:   Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm.   [ Time Frame: 12 months post implant ]

9.  Secondary:   Characterize Health Resource Utilization   [ Time Frame: 12 months post implant ]

10.  Secondary:   Characterize Randomized Days Alive Out of Hospital   [ Time Frame: 12 months post implant ]

11.  Secondary:   Characterize Subject Survival   [ Time Frame: 12 months post implant ]

12.  Secondary:   Characterize Medication Usage   [ Time Frame: 12 months post implant ]

13.  Secondary:   Characterize Intracardiac Pressure   [ Time Frame: 12 months post implant ]

14.  Secondary:   Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events   [ Time Frame: 12 months post implant ]

15.  Secondary:   Characterize NYHA Functional Class   [ Time Frame: baseline to 12 months post implant ]

16.  Secondary:   Characterize Distance Walked in Six Minutes   [ Time Frame: baseline to 12 months post implant ]

17.  Secondary:   Characterize Renal Function at the Baseline and 12-month Visit   [ Time Frame: baseline to 12 months post implant ]

18.  Secondary:   Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only)   [ Time Frame: implant ]

19.  Secondary:   Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only)   [ Time Frame: Implant ]

20.  Secondary:   Characterize Quality of Life at Baseline and 12-month Visit   [ Time Frame: baseline to 12 months post implant ]

21.  Secondary:   Characterize Arrhythmic Events   [ Time Frame: 12 months post implant ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
The study was terminated early after 400 of an estimated 1300 subjects required were randomized. The study was terminated due to a pressure lead integrity issue based on analysis of pressure leads from other clinical trials.  


Results Point of Contact:  
Name/Title: REDUCEhf Clinical Research Specialist
Organization: Medtronic CRDM
phone: 1-800-328-2518 ext 62736
e-mail: medtronicCRMtrials@medtronic.com


No publications provided by Medtronic Cardiac Rhythm Disease Management

Publications automatically indexed to this study:

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00354159     History of Changes
Other Study ID Numbers: 103
Study First Received: July 19, 2006
Results First Received: January 12, 2012
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration