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Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients (CARE-ESRD)
This study is currently recruiting participants.
Verified by Duke University, July 2009
First Received: July 2, 2009   Last Updated: July 6, 2009   History of Changes
Sponsor: Duke University
Collaborator: Medtronic
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00932659
  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 infomration (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: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment
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:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Arrhythmia Dialysis Kidney Failure
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hemodialysis patients
adult hemodialysis patients without a prior history of cardiac arrhythmias
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
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932659

Contacts
Contact: Sana Al-Khatib, MD 919-668-8649 alkha001@mc.duke.edu
Contact: Patrick Pun, MD 919-660-6865 patrick.pun@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Sana Al-Khatib, MD     919-668-8649     alkha001@mc.duke.edu    
Contact: Patrick Pun, MD     919-660-6865     patrick.pun@duke.edu    
Principal Investigator: Sana Al-Khatib, MD            
Sub-Investigator: Patrick Pun, MD            
Sponsors and Collaborators
Duke University
Medtronic
Investigators
Principal Investigator: Sana Al-Khatib, MD Duke University Health System
  More Information

Publications:
Huikuri HV, Castellanos A, Myerburg RJ. Sudden death due to cardiac arrhythmias. N Engl J Med. 2001 Nov 15;345(20):1473-82. Review. No abstract available.
Al-Khatib SM, Sanders GD, Bigger JT, Buxton AE, Califf RM, Carlson M, Curtis A, Curtis J, Fain E, Gersh BJ, Gold MR, Haghighi-Mood A, Hammill SC, Healey J, Hlatky M, Hohnloser S, Kim RJ, Lee K, Mark D, Mianulli M, Mitchell B, Prystowsky EN, Smith J, Steinhaus D, Zareba W; Expert panel participating in a Duke's Center for the Prevention of Sudden Cardiac Death conference. Preventing tomorrow's sudden cardiac death today: part I: Current data on risk stratification for sudden cardiac death. Am Heart J. 2007 Jun;153(6):941-50.
Goldenberg I, Moss AJ, McNitt S, Zareba W, Andrews ML, Hall WJ, Greenberg H, Case RB; Multicenter Automatic Defibrillator Implantation Trial-II Investigators. Relations among renal function, risk of sudden cardiac death, and benefit of the implanted cardiac defibrillator in patients with ischemic left ventricular dysfunction. Am J Cardiol. 2006 Aug 15;98(4):485-90. Epub 2006 Jun 19.
Herzog CA. Cardiac arrest in dialysis patients: approaches to alter an abysmal outcome. Kidney Int Suppl. 2003 May;(84):S197-200. Review.
Herzog CA. Can we prevent sudden cardiac death in dialysis patients? Clin J Am Soc Nephrol. 2007 May;2(3):410-2. Epub 2007 Mar 27. Review. No abstract available.
Lehrich RW, Pun PH, Tanenbaum ND, Smith SR, Middleton JP. Automated external defibrillators and survival from cardiac arrest in the outpatient hemodialysis clinic. J Am Soc Nephrol. 2007 Jan;18(1):312-20. Epub 2006 Dec 6.

Responsible Party: Duke University Health System ( Dr. Sana Al-Khatib )
Study ID Numbers: Pro0012031
Study First Received: July 2, 2009
Last Updated: July 6, 2009
ClinicalTrials.gov Identifier: NCT00932659     History of Changes
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Renal Insufficiency
Pathologic Processes
Heart Diseases
Urologic Diseases
Renal Insufficiency, Chronic
 Kidney Failure, Chronic
Cardiovascular Diseases
Kidney Diseases
Kidney Failure
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010



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