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OpenTrials
Completed

NCT Number: NCT00932659

Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

continuous cardiac monitoring device (REVEAL, Medtronic)

Device

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

Primary outcomes

  1. Number of Participants With a Significant Arrhythmia Detected

    Time frame: 6 months

Secondary outcomes

  1. Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Medtronic

Registry information

Official study title

Characterization of Cardiac Arrhythmias in End Stage Kidney Disease Patients on Hemodialysis Using an Implantable Continuous Cardiac Rhythm Monitoring Device: A Pilot Study

Acronym: CARE-ESRD

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 3, 2009
Registry last updated
Apr 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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