Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients

Arrhythmias, Cardiac Clinical Trial

— CARE-ESRD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932659
• Other study ID #: Pro00012031
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: April 11, 2013
• Start date: June 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. Epub 2006 Jun 19. — View Citation

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. — View Citation

Herzog CA. Cardiac arrest in dialysis patients: approaches to alter an abysmal outcome. Kidney Int Suppl. 2003 May;(84):S197-200. Review. — View Citation

Huikuri HV, Castellanos A, Myerburg RJ. Sudden death due to cardiac arrhythmias. N Engl J Med. 2001 Nov 15;345(20):1473-82. Review. — View 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. Epub 2006 Dec 6. — View Citation

USRDS Annual Data Report. Bethesda: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2006.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Significant Arrhythmia Detected		6 months	No
Secondary	Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias		6 months	No