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Completed

NCT Number: NCT01252823

Implantable Loop Recorder in Hemodialysis Patients

The purpose of this study is to use implantable loop recorder (ILR) in patients under chronic hemodialysis to record arrhythmias and conduction disorders and correlate them with hemodialysis parameters.

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Key information

Conditions

Hemodialysis Arrhythmias, Cardiac Cardiac Arrhythmia Cardiac Death Cardiovascular Diseases Death Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Saint Augustin, Bordeaux, France

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About this study

Primary cause of death in patients under chronic hemodialysis is Sudden Cardiac Death (SCD) (25% of all cause mortality). SCD is mainly due to cardiac arrhythmias (conduction disturbances or ventricular arrhythmias). These cardiac arrhythmias are highly sensitive to hydro-electrolytic disorders which are extremely frequent in patients under hemodialysis. In addition, other conditions leading to cardiac arrhythmias are frequent in this population such as ischemic myocardiopathy or dilated myocardiopathy. However, so far, little is known about the occurrence of arrhythmias because of studies using only standard Holter monitoring (24 to 48 hours monitoring at best).

The investigators sought to evaluate the incidence of cardiac arrhythmias by using an implantable loop recorder (ILR)(Reveal XT, Medtronic) that allows continuous rhythm monitoring for 24 months. This ILR will be implanted under local anesthesia.

Clinical follow-up will be performed during hemodialysis and rhythm management will be performed automatically using a remote-monitoring system (Carelink, Medtronic). Pre-programmed alerts (conduction disturbances, supra-ventricular arrhythmias or ventricular arrhythmias) recorded by the ILR will be sent automatically on a daily basis in our center. These data will be analyzed during week days from 9AM to 5PM. They will be reviewed by an electrophysiologists and depending on the potential lethality, the patients will be called and ask to come to the emergency room in case of high risk or the nephrologist will be contacted and he will see the patients during the next hemodialysis in case of on vital event.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients under chronic hemodialysis
  • Age between 45 and 80 yo
  • written informed consent
  • affiliated to the French Social Security system

Exclusion criteria

  • Pace-maker or Implantable Cardioverter Defibrillator
  • Active infection
  • Neoplasia or any pathology with a life expectancy <12 months
  • Cachexia
  • Patient with restricted civic rights by law

Treatment and study plan

Implantation of ILR

Device

Subcutaneous implantation of ILR under local anesthesia

Primary outcomes

  1. Occurrence of arrhythmia

    Time frame: Checked every days except Sundays and bank holidays during 24 Month

    • Type 1: Conduction disorders: 1A-Cardiac arrest, 1B-High degree AV Block, 1C-Sinus dysfunction (Sinus pause>3seconds, Bradycardia <30 bpm)
    • Type 2: Ventricular rhythm disorders ≥ 150 bpm: 2A-Polymorphic ventricular tachycardia, Torsades de pointe, Ventricular Fibrillation, 2B-Sustained ventricular tachycardia (>30 seconds), 2C- Non sustained ventricular tachycardia (>4 beats but <30 seconds)

Secondary outcomes

  1. Study correlation between arrhythmic events (primary outcome) and hemodialysis parameters (general: day of dialysis, length of dialysis;clinical: weight variation during dialysis...; biological: potassium level, potassium variation...; ECG)

    Time frame: three times per weeks, at each hemodialysis

  2. Incidence of supra-ventricular arrhythmia: 3A-Atrial Fibrillation, 3B-Atrial Tachycardia, 3C-Junctional tachycardia

    Time frame: Checked every days except Sundays and bank holidays during 24 Month

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients

Acronym: RYTHMODIAL

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2010
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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