NCT01252823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2010

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
25 days until next milestone

Study Start

First participant enrolled

December 28, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2016

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

5.2 years

First QC Date

November 4, 2010

Last Update Submit

November 23, 2017

Conditions

HemodialysisCardiac ArrhythmiaCardiac Death

Keywords

HemodialysisCardiac ArrhythmiaCardiac DeathImplantable Loop Recorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (1)

Implantable loop recorder (ILR) in hemodialysis patients

EXPERIMENTAL

implantation of loop recorder in hemodialysis patients

Device: Implantation of ILR

Interventions

Implantation of ILRDEVICE

Subcutaneous implantation of ILR under local anesthesia

Implantable loop recorder (ILR) in hemodialysis patients

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients under chronic hemodialysis
  • Age between 45 and 80 yo
  • written informed consent
  • affiliated to the French Social Security system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Clinique Saint Augustin

Bordeaux, 33074, France

Location

University Hospital of Bordeaux

Bordeaux, 33076, France

Location

Polyclinique Bordeaux-Nord Aquitaine

Bordeaux, 33077, France

Location

CH de Haguenau

Haguenau, France

Location

CH de Libourne

Libourne, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CHU de Strasbourg

Strasbourg, 67091, France

Location

CHU de Toulouse

Toulouse, France

Location

Related Publications (1)

  • 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.

    PMID: 30089568DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacDeath

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian COMBE, MD-PhD

    University Hospital of Bordeaux, France

    STUDY CHAIR

  • Antoine BENARD, MD

    USMR, University Hospital of Bordeaux, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2010

First Posted

December 3, 2010

Study Start

December 28, 2010

Primary Completion

February 29, 2016

Study Completion

February 29, 2016

Last Updated

November 27, 2017

Record last verified: 2017-11

Locations

FR(9)