Implantable Loop Recorder in Hemodialysis Patients

Hemodialysis Clinical Trial

— RYTHMODIAL  

Official title:

Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252823
• Other study ID #: CHUBX 2010/33
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: November 23, 2017
• Start date: December 28, 2010
• Est. completion date: February 29, 2016

Study information

• Verified date: November 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 29, 2016
• Est. primary completion date: February 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Cardiac Death
• Death
• Hemodialysis

Intervention

Device:
• Implantation of ILR
Subcutaneous implantation of ILR under local anesthesia

Locations

Country	Name	City	State
France	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 Nantes	Nantes
France	CHU de Rennes	Rennes
France	CHU de Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of arrhythmia	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)	Checked every days except Sundays and bank holidays during 24 Month
Secondary	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
Secondary	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