Implantable Loop Recorder in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hemodialysis; Cardiac Arrhythmia; Cardiac Death
• Interventions: Device: Implantation of ILR

• Registration Number: NCT01252823
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Study Start: 2010-12-28
• Primary Completion: 2016-02-29
• Study Completion: 2016-02-29
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-23
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantable loop recorder (ILR) in hemodialysis patients	Implantation of ILR	implantation of loop recorder in hemodialysis patients

Primary Outcome Measures

Name	Time	Method
Occurrence of arrhythmia	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 Outcome Measures

Name	Time	Method
Incidence of supra-ventricular arrhythmia: 3A-Atrial Fibrillation, 3B-Atrial Tachycardia, 3C-Junctional tachycardia	Checked every days except Sundays and bank holidays during 24 Month
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)	three times per weeks, at each hemodialysis

Trial Locations

Locations (9)

Clinique Saint Augustin; 🇫🇷 Bordeaux, France

Polyclinique Bordeaux-Nord Aquitaine; 🇫🇷 Bordeaux, France

University Hospital of Bordeaux; 🇫🇷 Bordeaux, France

CH de Haguenau; 🇫🇷 Haguenau, France

CH de Libourne; 🇫🇷 Libourne, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Toulouse; 🇫🇷 Toulouse, France