Clinical trial NCT01252823: Implantable Loop Recorder in Hemodialysis Patients
Official title: Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Cardiac Arrhythmia
Cardiac Death
Keywords: Hemodialysis
Cardiac Arrhythmia
Cardiac Death
Implantable Loop Recorder
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 72
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of arrhythmia
timeFrame: Checked every days except Sundays and bank holidays during 24 Month
Secondary outcomes:
measure: 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)
timeFrame: three times per weeks, at each hemodialysis
measure: Incidence of supra-ventricular arrhythmia: 3A-Atrial Fibrillation, 3B-Atrial Tachycardia, 3C-Junctional tachycardia
timeFrame: Checked every days except Sundays and bank holidays during 24 Month
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
city: Bordeaux
country: France
facility: Polyclinique Bordeaux-Nord Aquitaine
city: Haguenau
country: France
facility: CH de Haguenau
city: Libourne
country: France
facility: CH de Libourne
city: Nantes
country: France
facility: CHU de Nantes
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital of Bordeaux, France
name: Christian COMBE, MD-PhD
role: STUDY_CHAIR
affiliation: USMR, University Hospital of Bordeaux, France
name: Antoine BENARD, MD
role: STUDY_CHAIR
References:
citation: Sacher F, Jesel L, Borni-Duval C, De Precigout V, Lavainne F, Bourdenx JP, Haddj-Elmrabet A, Seigneuric B, Keller A, Ott J, Savel H, Delmas Y, Bazin-Kara D, Klotz N, Ploux S, Buffler S, Ritter P, Rondeau V, Bordachar P, Martin C, Deplagne A, Reuter S, Haissaguerre M, Gourraud JB, Vigneau C, Mabo P, Maury P, Hannedouche T, Benard A, Combe C. Cardiac Rhythm Disturbances in Hemodialysis Patients: Early Detection Using an Implantable Loop Recorder and Correlation With Biological and Dialysis Parameters. JACC Clin Electrophysiol. 2018 Mar;4(3):397-408. doi: 10.1016/j.jacep.2017.08.002. Epub 2017 Sep 27.