Implantable Loop Recorder in Hemodialysis Patients

NCT ID: NCT01252823

Last Updated: 2017-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-28
• Study Completion Date: 2016-02-29

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.

Conditions

Hemodialysis; Cardiac Arrhythmia; Cardiac Death

Keywords

Hemodialysis; Cardiac Arrhythmia; Cardiac Death; Implantable Loop Recorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Implantable loop recorder (ILR) in hemodialysis patients

implantation of loop recorder in hemodialysis patients

Group Type: EXPERIMENTAL

Implantation of ILR

Intervention Type: DEVICE

Subcutaneous implantation of ILR under local anesthesia

Interventions

Implantation of ILR

Subcutaneous implantation of ILR under local anesthesia

Intervention Type: DEVICE

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian COMBE, MD-PhD

Role: STUDY_CHAIR

University Hospital of Bordeaux, France

Antoine BENARD, MD

Role: STUDY_CHAIR

USMR, University Hospital of Bordeaux, France

Locations

Clinique Saint Augustin

Bordeaux, , France

University Hospital of Bordeaux

Bordeaux, , France

Polyclinique Bordeaux-Nord Aquitaine

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, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 30089568 (View on PubMed)

Other Identifiers

CHUBX 2010/33

Identifier Type: -

Identifier Source: org_study_id