Implantable Loop Recorder in Hemodialysis Patients (RYTHMODIAL)

November 23, 2017 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33074
        • Clinique Saint Augustin
      • Bordeaux, France, 33076
        • University Hospital of Bordeaux
      • Bordeaux, France, 33077
        • Polyclinique Bordeaux-Nord Aquitaine
      • Haguenau, France
        • Ch de Haguenau
      • Libourne, France
        • CH de Libourne
      • Nantes, France, 44093
        • CHU de Nantes
      • Rennes, France, 35033
        • CHU de Rennes
      • Strasbourg, France, 67091
        • CHU de Strasbourg
      • Toulouse, France
        • CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of arrhythmia
Time Frame: 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)
Checked every days except Sundays and bank holidays during 24 Month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Checked every days except Sundays and bank holidays during 24 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Christian COMBE, MD-PhD, University Hospital of Bordeaux, France
  • Study Chair: Antoine BENARD, MD, USMR, University Hospital of Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2010

Primary Completion (Actual)

February 29, 2016

Study Completion (Actual)

February 29, 2016

Study Registration Dates

First Submitted

November 4, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 23, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2010/33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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