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Trial registered on ANZCTR


Registration number
ACTRN12613001302741
Ethics application status
Approved
Date submitted
26/09/2013
Date registered
22/11/2013
Date last updated
18/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Study looking at Cardiovascular Effects of Closure of Arteriovenous Fistulae after Kidney Transplantation
Scientific title
A randomised controlled study looking at the effect of closure of arteriovenous fistulae versus non closure after kidney transplantation on cardiac indices particularly left ventricular mass
Secondary ID [1] 283315 0
Nil
Universal Trial Number (UTN)
U1111-1148-5205
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
kidney transplant recipients 290202 0
Condition category
Condition code
Renal and Urogenital 290595 290595 0 0
Other renal and urogenital disorders
Cardiovascular 290961 290961 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will have cardiac MRI scan performed at baseline and also after six months. This scan takes approximately 40 minutes. Subjects randomised to AV fistula closure will undergo a small surgical procedure under local anaethesia or arm block, where an incision is made close to the AV fistula anastomoses. The venous limb is ligated and the wound is closed. This procedure will take approximately 15 to 20 minutes.
Intervention code [1] 288034 0
Prevention
Comparator / control treatment
The subjects in the control group will only need to undergo two cardiac MR scans, one at baseline and then 6 months later. There is no surgical procedure involved.
Control group
Active

Outcomes
Primary outcome [1] 290605 0
The primary outcome will be assessed by looking at improvement in the left ventricular mass. A difference of more than 9.5 gram after 6 months has shown to be significant in previous studies. The LV mass will be measured by cardiac MR scan.
Timepoint [1] 290605 0
6 months
Secondary outcome [1] 304890 0
LV end diastolic volumes measured by cardiac MR scan
Timepoint [1] 304890 0
6 months
Secondary outcome [2] 305632 0
LV end systolic volume measured by cardiac MR scan
Timepoint [2] 305632 0
6 months
Secondary outcome [3] 305633 0
Left atrial enlargement measured by cardiac MR scan
Timepoint [3] 305633 0
6 months
Secondary outcome [4] 305634 0
right atrial enlargement measured by cardiac MR scan
Timepoint [4] 305634 0
6 months
Secondary outcome [5] 305635 0
pulmonary flow measured by cardiac MR scan
Timepoint [5] 305635 0
6 months
Secondary outcome [6] 353054 0
LV ejection fraction measured by cardiac MR scan
Timepoint [6] 353054 0
6 months
Secondary outcome [7] 353055 0
Cardiac output and cardiac index measured by cardiac MR scan
Timepoint [7] 353055 0
6 months
Secondary outcome [8] 353056 0
Ipsilateral brachial artery flow
Timepoint [8] 353056 0
6 months
Secondary outcome [9] 353057 0
N terminal Pro brain natriuretic peptide
Timepoint [9] 353057 0
6 months

Eligibility
Key inclusion criteria
Aged 18-80, treated at the Royal Adelaide Hospital Renal Unit following successful Renal Transplantation > 12 months, who continue to have a functioning AV Fistula. Renal functions should be stable (eGFR> 60 ml/min) for at least 5 months prior to enrolment or one deemed at low risk for transplant failure by treating physician.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Solid organ or haematological malignancy in last 5 years
Presence of contraindications to MRI
Pregnancy
Physician concern regarding closure of AV fistula

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be done in the closed sealed envelope format. Patients will be allocated by 2 main investigators. The sealed envelopes will be put together in a box. At the time of randomisation an envelope is blindly picked up after shaking the box well. There are numbers in the sealed envelope that will be allocated to a particular patient at the time of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A sequence will be generated using a computer software (www.randomizer.org) to generate numbers in each arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
In a previous controlled study of AVF closure utilizing echocardiography, no change in LV mass index was demonstrated in the control group over a period of 4 months. Therefore, we made an assumption that the change in LV mass in the control group was likely to be minimal. However, to ensure that the study was not underpowered; given that CMR is a more sensitive tool than echocardiography in detecting the changes in LV mass, likelihood of kidney transplantation in itself leading to regression of LVM and lack of previous studies using CMR in this population, a pre-planned blinded sample size re-estimation will be undertaken after 15 subjects in each arm have completed the study.

Recruitment
Recruitment status
Completed
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)
NSW,SA
Recruitment hospital [1] 1547 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 1548 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 12199 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [4] 12200 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 7385 0
5000 - Adelaide
Recruitment postcode(s) [2] 24374 0
5011 - Woodville
Recruitment postcode(s) [3] 24375 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 288047 0
Hospital
Name [1] 288047 0
Royal Adelaide Hospital
Address [1] 288047 0
North Terrace
Adelaide, SA
5000
Country [1] 288047 0
Australia
Primary sponsor type
Hospital
Name
Renal Unit, Royal Adelaide Hospital
Address
Royal Adelaide Hospital,
North Terrace,
SA 5000
Country
Australia
Secondary sponsor category [1] 286772 0
Hospital
Name [1] 286772 0
Cardiology Unit, Royal Adelaide Hospital
Address [1] 286772 0
Royal Adelaide Hospital,
North Terrace,
SA 5000
Country [1] 286772 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289973 0
Research Ethics Committee, RAH
Ethics committee address [1] 289973 0
Level 3, Hanson Institute,
IMVS
Frome road, RAH
Adelaide
SA 5000
Ethics committee country [1] 289973 0
Australia
Date submitted for ethics approval [1] 289973 0
Approval date [1] 289973 0
28/08/2013
Ethics approval number [1] 289973 0
130232

Summary
Brief summary
Arteriovenous fistulae continue to function in patients who have had a successful kidney transplant. This adds to the cardiovascular burden in this group of patients. Closure of these fistulae have been shown to improve cardiovascular outcomes in observational studies. If this is demonstrated in a randomised controlled trial, this could help guide nephrologists to form definite opinion as practice varies widely among hospitals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43322 0
Dr Nitesh Rao
Address 43322 0
Department of nephrology,
Royal Adelaide hospital
North Terrace,
Adelaide
SA 5000
Country 43322 0
Australia
Phone 43322 0
+61422362079
Fax 43322 0
Email 43322 0
nitesh.rao@health.sa.gov.au
Contact person for public queries
Name 43323 0
Dr Nitesh Rao
Address 43323 0
Department of nephrology,
Royal Adelaide hospital
North Terrace,
Adelaide
SA 5000
Country 43323 0
Australia
Phone 43323 0
+61422362079
Fax 43323 0
Email 43323 0
nitesh.rao@health.sa.gov.au
Contact person for scientific queries
Name 43324 0
Dr Nitesh Rao
Address 43324 0
Department of nephrology,
Royal Adelaide hospital
North Terrace,
Adelaide
SA 5000
Country 43324 0
Australia
Phone 43324 0
+61422362079
Fax 43324 0
Email 43324 0
nitesh.rao@health.sa.gov.au

No data has been provided for results reporting
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