RYTHMODIAL: Implantable Loop Recorder in Hemodialysis Patients

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT01252823

Collaborator

(none)

Enrollment

Locations

Arm

62.1

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis Cardiac Arrhythmia Cardiac Death	Device: Implantation of ILR	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients

Actual Study Start Date :

Dec 28, 2010

Actual Primary Completion Date :

Feb 29, 2016

Actual Study Completion Date :

Feb 29, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Implantable loop recorder (ILR) in hemodialysis patients implantation of loop recorder in hemodialysis patients	Device: Implantation of ILR Subcutaneous implantation of ILR under local anesthesia

Arm

Intervention/Treatment

Experimental: Implantable loop recorder (ILR) in hemodialysis patients

implantation of loop recorder in hemodialysis patients

Device: Implantation of ILR

Subcutaneous implantation of ILR under local anesthesia

Outcome Measures

Primary Outcome Measures

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

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique Saint Augustin	Bordeaux	France	33074
2	University Hospital of Bordeaux	Bordeaux	France	33076
3	Polyclinique Bordeaux-Nord Aquitaine	Bordeaux	France	33077
4	CH de Haguenau	Haguenau	France
5	CH de Libourne	Libourne	France
6	CHU de Nantes	Nantes	France	44093
7	CHU de Rennes	Rennes	France	35033
8	CHU de Strasbourg	Strasbourg	France	67091
9	CHU de Toulouse	Toulouse	France