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Trial registered on ANZCTR


Registration number
ACTRN12613001326785
Ethics application status
Approved
Date submitted
11/11/2013
Date registered
2/12/2013
Date last updated
14/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identification and characterisation of risk factors for atrial and ventricular arrhythmias in chronic kidney disease (CKD) patients using implantable cardiac monitoring
Scientific title
Identification and characterisation of risk factors for sudden cardiac death in chronic kidney disease patients on regular haemodialysis using an implantable cardiac monitor
Secondary ID [1] 283496 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dialysis 290414 0
Sudden Cardiac Death 290415 0
Chronic Kidney Disease 290548 0
Condition category
Condition code
Cardiovascular 290806 290806 0 0
Other cardiovascular diseases
Renal and Urogenital 290947 290947 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The procedural component of the research will involve insertion of the implantable loop recorder under the skin in the left front chest wall region. This will take approximately 15-20 minutes and is performed under local anaesthetic. The recorder will be implanted for 2 years over which the participant will be monitored on a continuing regular basis.
Intervention code [1] 288203 0
Early detection / Screening
Intervention code [2] 288372 0
Prevention
Comparator / control treatment
A control group for comparison consisting of patients (who may or may not have CKD) with an implantable loop recorder inserted (up to 1 year prior to participation in this study) for routine clinical indications such as lightheadedness or palpitations for investigation will also be followed up.
Control group
Historical

Outcomes
Primary outcome [1] 290802 0
Sudden cardiac death will be determined by a consensus adjudication committee after assessment of electrocardiogram records of the implantable loop recorder, autopsy reports, holter recordings or telemetry tracings and hospital discharge documentation/medical records.
Timepoint [1] 290802 0
Assessed at 12 and 24 months from insertion of implantable loop recorder.
Secondary outcome [1] 305328 0
Significant Arrhythmias will be determined by a consensus adjudication committee after assessment of electrocardiogram records of the implantable loop recorder, holter recordings or telemetry tracings and hospital discharge documentation/medical records.
Timepoint [1] 305328 0
Assessed at 12 and 24 months from insertion of implantable loop recorder.

Eligibility
Key inclusion criteria
1. Any CKD patient on haemodialysis
2. Stable medical therapy for at least one month.
3. All patients must have no prior history of clinical ventricular tachyarrhythmias (including ventricular fibrillation or cardiac arrest) or syncope.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pacemaker or Automatic Implantable Cardioverter-Defibrillator in-situ
2. Unstable angina pectoris
3. Uncontrolled hypertension.
4. Known coagulopathy, thrombophilia or contraindications to full systemic anticoagulation
with heparin or warfarin (e.g. haemorrhagic stroke, active bleeding, heparin induced
thrombocytopenic thrombotic syndrome etc.)
5. Inability to provide informed consent
6. Women who are pregnant
7. Children and/or young people (ie. <18 years)
8. Patients experiencing NYHA class IV symptoms and/or LVEF < 35%

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Sample size estimation for this prospective cohort with 95% confidence level and probability of event exposure at
25-30% (approximate 1 in 4 risk of SCD in haemodialysis patients) revealed sample size calculation of this population
proportion to be 50 participants.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1642 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 1643 0
Western Hospital - Footscray
Recruitment postcode(s) [1] 7530 0
3011 - Footscray
Recruitment postcode(s) [2] 7529 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 288200 0
Charities/Societies/Foundations
Name [1] 288200 0
National Heart Foundation
Address [1] 288200 0
Level 12/500 Collins Street
Melbourne VIC 3000
Country [1] 288200 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
St Jude Medical
Address
c2/63-85 Turner St
Port Melbourne VIC 3207
Country
Australia
Secondary sponsor category [1] 286926 0
None
Name [1] 286926 0
Address [1] 286926 0
Country [1] 286926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290112 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 290112 0
Office for Research
Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital VIC 3050
Ethics committee country [1] 290112 0
Australia
Date submitted for ethics approval [1] 290112 0
Approval date [1] 290112 0
18/07/2012
Ethics approval number [1] 290112 0
2012.055

Summary
Brief summary
The purpose of this project is to study the abnormal processes in the heart that can occur in people with chronic kidney disease. These processes may lead to significant heart rhythm disturbances. In this study we will assess people with chronic kidney disease who may be at high risk of developing these disorders. By doing so we aim to identify factors in chronic kidney disease that may lead to development of life-threatening heart rhythm disorders and determine potential measures to prevent sudden death.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44010 0
Dr Michael Wong
Address 44010 0
Level 2, Department of Cardiology
The Royal Melbourne Hospital,
City Campus, Grattan Street,
Parkville, Victoria,
3050
Country 44010 0
Australia
Phone 44010 0
+613 93427133
Fax 44010 0
Email 44010 0
drmichaelwong@live.com
Contact person for public queries
Name 44011 0
Dr Michael Wong
Address 44011 0
Level 2, Department of Cardiology
The Royal Melbourne Hospital,
City Campus, Grattan Street,
Parkville, Victoria,
3050
Country 44011 0
Australia
Phone 44011 0
+613 93427133
Fax 44011 0
Email 44011 0
drmichaelwong@live.com
Contact person for scientific queries
Name 44012 0
Dr Michael Wong
Address 44012 0
Level 2, Department of Cardiology
The Royal Melbourne Hospital,
City Campus, Grattan Street,
Parkville, Victoria,
3050
Country 44012 0
Australia
Phone 44012 0
+613 93427133
Fax 44012 0
Email 44012 0
drmichaelwong@live.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary