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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

July 2, 2009
April 11, 2013
June 2009
February 2011   (final data collection date for primary outcome measure)
Number of Participants With a Significant Arrhythmia Detected [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary endpoint of the study is the type and frequency of cardiac arrhythmias experienced by study subjects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00932659 on ClinicalTrials.gov Archive Site
Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias [ Time Frame: 6 months ] [ Designated as safety issue: No ]
We will examine the frequency and type of arrhythmias which occur during specific time periods in relation to the dialysis procedure: 0-24 hrs from start of dialysis, 24-48 hrs prior to next dialysis, and >48 hours prior to scheduled dialysis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients
Characterization of Cardiac Arrhythmias in End Stage Kidney Disease Patients on Hemodialysis Using an Implantable Continuous Cardiac Rhythm Monitoring Device: A Pilot Study

Hemodialysis patients have a rate of fatal arrhythmias that is 40 times greater than the general population, but the causes and types of fatal arrhythmias they experience is unclear. The purpose of this prospective observational cohort study is to capture and characterize occult arrhythmias which occur in hemodialysis patients over a 6 month period. After informed consent and baseline assessment, 30 adult hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device (REVEAL, Medtronic). Three followup visits will be scheduled to download device data and quantify the number of potentially malignant arrhythmias which occur in study subjects during the 6 month period. Additionally, captured events will be monitored remotely via regular patient initiated transmission of device data every 2 weeks. Any serious occult arrhythmias detected will be immediately acted upon with a predefined management algorithm. Descriptive data and simple proportions will be used to describe the incidence and types of arrhythmias among the study cohort. Risks of this study include 1) potential loss of patient confidentiality 2) risks related to insertion of device including pocket hematoma, device infection, pain and discomfort secondary to procedure. These will be minimized by strict security measures to protect each patient's protected health information (PHI), preprocedural screening and insertion of monitoring devices by highly trained operators, and frequent careful direct patient followup.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Duke hemodialysis patients with end stage renal disease

Arrhythmias, Cardiac
Device: 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
Hemodialysis patients
This is a single arm observational study. The single arm consists of adult hemodialysis patients without a prior history of cardiac arrhythmias who will be implanted with a continuous cardiac monitoring device (REVEAL, Medtronic) for an FDA approved indication.
Intervention: Device: continuous cardiac monitoring device (REVEAL, Medtronic)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Greater than 18 years of age
  • ESRD receiving hemodialysis for at least 3 months

Exclusion Criteria:

  • Inability to give informed consent
  • Pre-existing implantable cardiac device (pacemaker or ICD) or imminent device implantation
  • Imminent renal transplantation
  • Life expectancy < 1yr
  • PT-INR or aPTT > 1.7 upper limit of normal (ULN) or history of bleeding diathesis
  • Unstable medical condition as deemed by primary nephrologist or study staff
  • Known sustained ventricular tachycardia due to non-reversible cause.
  • Active infection
  • Known atrial fibrillation
  • Women who are pregnant
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932659
Pro00012031
Yes
Duke University
Duke University
Medtronic
Principal Investigator: Sana Al-Khatib, MD Duke University Health System
Duke University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP