Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients

NCT00932659 | Completed Results DMC

• 1 other identifier: Pro00012031
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmias, Cardiac

Keywords

End-Stage Renal Disease; Hemodialysis; Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Significant Arrhythmia Detected

  6 months

Secondary Outcomes (1)

• Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias

  6 months

Study Arms (1)

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)

Interventions

continuous cardiac monitoring device (REVEAL, Medtronic) DEVICE

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

Hemodialysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Duke hemodialysis patients with end stage renal disease

You may qualify if:

• Greater than 18 years of age
• ESRD receiving hemodialysis for at least 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Medtronic: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (7)

• 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.

  PMID: 11794197 BACKGROUND

• 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.

  PMID: 17540194 BACKGROUND

• 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.

  PMID: 16893702 BACKGROUND

• 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.

  PMID: 12694343 BACKGROUND

• 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.

  PMID: 17699443 BACKGROUND

• 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.

  PMID: 17151332 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Limitations and Caveats

This is the 1st study of an implantable cardiac monitor in HD patients. Despite minimally invasive device implantation,collaboration between cardiology and nephrology, a large population of available subjects, we were able to enroll only 8 patients.

Results Point of Contact

• Title: Patrick Pun, MD, MHS
• Organization: Duke University

patrick.pun@duke.edu

919-660-6865

Study Officials

• Sana Al-Khatib, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 3, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 19, 2013
• Results First Posted: March 27, 2013

Record last verified: 2013-02

Locations

US (1)