Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients (CARE-ESRD)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00932659
First received: July 2, 2009
Last updated: April 11, 2013
Last verified: February 2013
Results First Received: December 13, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Arrhythmias, Cardiac
Intervention: Device: continuous cardiac monitoring device (REVEAL, Medtronic)

  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 recruited from June 2009 to August 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
Single Arm: Hemodialysis Patients Implanted With REVEAL Device

adult hemodialysis patients without a prior history of cardiac arrhythmias

continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up


Participant Flow:   Overall Study
    Single Arm: Hemodialysis Patients Implanted With REVEAL Device  
STARTED     8  
COMPLETED     8  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Single Arm: Hemodialysis Patients Implanted With REVEAL Device

adult hemodialysis patients without a prior history of cardiac arrhythmias

continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up


Baseline Measures
    Single Arm: Hemodialysis Patients Implanted With REVEAL Device  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 3  
Gender  
[units: participants]
 
Female     3  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures
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1.  Primary:   Number of Participants With a Significant Arrhythmia Detected   [ Time Frame: 6 months ]

2.  Secondary:   Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias   [ Time Frame: 6 months ]


  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 NOT 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.


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
This is the 1st study of an implantable cardiac monitor in HD patients. Despite minimally invasive device implantation,collaboration between cardiology and nephrology, a large population of available subjects, we were able to enroll only 8 patients.  


Results Point of Contact:  
Name/Title: Patrick Pun, MD, MHS
Organization: Duke University
phone: 919-660-6865
e-mail: patrick.pun@duke.edu


Publications:
USRDS Annual Data Report. Bethesda: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2006.


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00932659     History of Changes
Other Study ID Numbers: Pro00012031
Study First Received: July 2, 2009
Results First Received: December 13, 2012
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board