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Implantable Loop Recorder in Hemodialysis Patients (RYTHMODIAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01252823
First received: November 4, 2010
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Hemodialysis
Cardiac Arrhythmia
Cardiac Death
Device: Implantation of ILR

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: December 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252823

Locations
France
Clinique Saint Augustin
Bordeaux, France, 33074
Polyclinique Bordeaux-Nord Aquitaine
Bordeaux, France, 33077
University Hospital of Bordeaux
Bordeaux, France, 33076
CH de Haguenau
Haguenau, France
CH de Libourne
Libourne, France
CHU de Nantes
Nantes, France, 44093
CHU de Rennes
Rennes, France, 35033
CHU de Strasbourg
Strasbourg, France, 67091
CHU de Toulouse
Toulouse, France
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01252823     History of Changes
Other Study ID Numbers: CHUBX 2010/33
Study First Received: November 4, 2010
Last Updated: August 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Hemodialysis
Cardiac Arrhythmia
Cardiac Death
Implantable Loop Recorder

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Death
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014