Implantable Loop Recorder in Hemodialysis Patients (RYTHMODIAL)

University Hospital of Bordeaux

Status: Completed

Conditions: Cardiac Death; Hemodialysis; Cardiac Arrhythmia

Treatments: Device: Implantation of ILR

Study type: Interventional

Funder types: Other

Identifiers

NCT01252823

CHUBX 2010/33

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Implantable loop recorder (ILR) in hemodialysis patients

Experimental group

Description:

implantation of loop recorder in hemodialysis patients

Treatment:

Device: Implantation of ILR