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
  Purpose

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.


Condition Intervention
Arrhythmias, Cardiac
Device: continuous cardiac monitoring device (REVEAL, Medtronic)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Cardiac Arrhythmias in End Stage Kidney Disease Patients on Hemodialysis Using an Implantable Continuous Cardiac Rhythm Monitoring Device: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of Participants With a Significant Arrhythmia Detected [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: June 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Duke hemodialysis patients with end stage renal disease

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932659

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Medtronic
Investigators
Principal Investigator: Sana Al-Khatib, MD Duke University Health System
  More Information

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

Keywords provided by Duke University:
End-Stage Renal Disease
Hemodialysis
Cardiac Arrhythmias

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014