Implantable Loop Recorder in Hemodialysis Patients (RYTHMODIAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01252823
First received: November 4, 2010
Last updated: November 20, 2013
Last verified: November 2013

November 4, 2010
November 20, 2013
December 2010
December 2015   (final data collection date for primary outcome measure)
Occurrence of arrhythmia [ Time Frame: Checked every days except Sundays and bank holidays during 24 Month ] [ Designated as safety issue: Yes ]
  • 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)
Occurrence of arrhythmia [ Time Frame: Checked every days except Sundays and bank holidays during 18 Month ] [ Designated as safety issue: Yes ]
  • Conduction disorders : Sinus pause>3seconds, Bradycardia <30 seconds, High degree AtrioVentricular Block
  • Excitation disorders: Supra-Ventricular arrhythmias (atrial tachycardia, flutter or fibrillation) or ventricular arrhythmias (polymorphic premature ventricular contractions, Non sustained or sustained ventricular tachycardia, Torsades de pointe, Ventricular Fibrillation)
Complete list of historical versions of study NCT01252823 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Implantable Loop Recorder in Hemodialysis Patients
Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hemodialysis
  • Cardiac Arrhythmia
  • Cardiac Death
Device: Implantation of ILR
Subcutaneous implantation of ILR under local anesthesia
Experimental: Implantable loop recorder (ILR) in hemodialysis patients
implantation of loop recorder in hemodialysis patients
Intervention: Device: Implantation of ILR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
45 Years to 80 Years
No
Contact: Frédéric SACHER, MD (0)5.57.65.64.71 ext +33 frederic.sacher@chu-bordeaux.fr
Contact: Rozenn MINGAM (0)5.57.62.31.72 ext +33 rozenn.mingam@chu-bordeaux.fr
France
 
NCT01252823
CHUBX 2010/33
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Study Chair: Christian COMBE, MD-PhD University Hospital of Bordeaux, France
Study Chair: Antoine BENARD, MD USMR, University Hospital of Bordeaux, France
University Hospital, Bordeaux
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP