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

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: continuous cardiac monitoring device (REVEAL, Medtronic)

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Duke hemodialysis patients with end stage renal disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With a Significant Arrhythmia Detected	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias	6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Medtronic
• Investigators: Principal Investigator: Sana Al-Khatib, MD, Duke Health

Publications and helpful links

General Publications

• Huikuri HV, Castellanos A, Myerburg RJ. Sudden death due to cardiac arrhythmias. N Engl J Med. 2001 Nov 15;345(20):1473-82. doi: 10.1056/NEJMra000650. 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. doi: 10.1016/j.ahj.2007.03.003.
• 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. doi: 10.1016/j.amjcard.2006.03.025. 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. doi: 10.1046/j.1523-1755.63.s84.17.x.
• Herzog CA. Can we prevent sudden cardiac death in dialysis patients? Clin J Am Soc Nephrol. 2007 May;2(3):410-2. doi: 10.2215/CJN.01130307. Epub 2007 Mar 27. 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. doi: 10.1681/ASN.2006040392. Epub 2006 Dec 6.
• USRDS Annual Data Report. Bethesda: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2006.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): February 1, 2011

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 2, 2009
• First Posted (ESTIMATE): July 3, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 19, 2013
• Last Update Submitted That Met QC Criteria: April 11, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Hemodialysis; Cardiac Arrhythmias; End-Stage Renal Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: Pro00012031