Clinical trial NCT00932659: Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Keywords: End-Stage Renal Disease
Hemodialysis
Cardiac Arrhythmias
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2009-07-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Duke hemodialysis patients with end stage renal disease

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With a Significant Arrhythmia Detected
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Sana Al-Khatib, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: USRDS Annual Data Report. Bethesda: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2006.