HemodialysisRYTHMODIALNCT01252823
Implantable Loop Recorder in Hemodialysis Patients
A study testing Implantation of ILR in people with Hemodialysis and Cardiac Arrhythmia, run by University Hospital, Bordeaux at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Hemodialysis, Cardiac Arrhythmia, Cardiac Death
- What is being tested?
- Implantation of ILR
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 9 sitesFrance
- Study dates
- 28 Dec 2010to 29 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under chronic hemodialysis
- Age between 45 and 80 yo
- written informed consent
- affiliated to the French Social Security system
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Clinique Saint Augustin
Bordeaux, 33074
University Hospital of Bordeaux
Bordeaux, 33076
Polyclinique Bordeaux-Nord Aquitaine
Bordeaux, 33077
CH de Haguenau
Haguenau
CH de Libourne
Libourne
CHU de Nantes
Nantes, 44093
CHU de Rennes
Rennes, 35033
CHU de Strasbourg
Strasbourg, 67091
CHU de Toulouse
Toulouse
About this study
Official title: 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.
Read the 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
- Being tested
- Implantation of ILR
- Keywords
- Hemodialysis, Cardiac Arrhythmia, Cardiac Death, Implantable Loop Recorder
- Medical subject headings
- Arrhythmias, Cardiac, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of ILRDevice
Subcutaneous implantation of ILR under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Implantable loop recorder (ILR) in hemodialysis patients | Experimental | implantation of loop recorder in hemodialysis patients Receives: Device: Implantation of ILR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: three times per weeks, at each hemodialysis
Incidence of supra-ventricular arrhythmia: 3A-Atrial Fibrillation, 3B-Atrial Tachycardia, 3C-Junctional tachycardia
Measured: Checked every days except Sundays and bank holidays during 24 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study start28 Dec 2010
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian COMBE, MD-PhD, Study chair, University Hospital of Bordeaux, FranceAntoine BENARD, MD, Study chair, USMR, University Hospital of Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252823
- Sponsor's protocol ID
- CHUBX 2010/33
- Acronym
- RYTHMODIAL
- Status last verified
- Nov 2017
- First submitted
- 4 Nov 2010
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30089568
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01252823
- Acronym / sponsor ID
- RYTHMODIAL / CHUBX 2010/33
- Conditions
- Hemodialysis, Cardiac Arrhythmia, Cardiac Death
- Keywords
- Hemodialysis, Cardiac Arrhythmia, Cardiac Death, Implantable Loop Recorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 28 Dec 2010 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable loop recorder (ILR) in hemodialysis patients | Experimental | Device: Implantation of ILRimplantation of loop recorder in hemodialysis patients |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients under chronic hemodialysis
- Age between 45 and 80 yo
- written informed consent
- affiliated to the French Social Security system
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of ILRSubcutaneous implantation of ILR under local anesthesia | Device | Implantable loop recorder (ILR) in hemodialysis patients |
Primary outcome
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)
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Derived from this study: PubMed 30089568Sacher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian COMBE, MD-PhD study chair
University Hospital of Bordeaux, France
Antoine BENARD, MD study chair
USMR, University Hospital of Bordeaux, France
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of ILR in people with Hemodialysis and Cardiac Arrhythmia, run by University Hospital, Bordeaux at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of arrhythmia (time frame: Checked every days except Sundays and bank holidays during 24 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01252823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.