This trial is active, not recruiting.

Conditions hemodialysis, cardiac arrhythmia, cardiac death
Treatment implantation of ilr
Sponsor University Hospital, Bordeaux
Start date December 2010
End date November 2015
Trial size 72 participants
Trial identifier NCT01252823, CHUBX 2010/33


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
implantation of loop recorder in hemodialysis patients
implantation of ilr
Subcutaneous implantation of ILR under local anesthesia

Primary Outcomes

Occurrence of arrhythmia
time frame: Checked every days except Sundays and bank holidays during 24 Month

Secondary Outcomes

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
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

Eligibility Criteria

Male or female participants from 45 years up to 80 years old.

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

Additional Information

Official title Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.