A Randomised Controlled Study looking at Cardiovascular Effects of Closure of Arteriovenous Fistulae after Kidney Transplantation

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001302741

Enrollment

Registered

2013-11-22

Start date

2013-10-02

Completion date

2016-02-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

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.

Exclusion criteria

Solid organ or haematological malignancy in last 5 years Presence of contraindications to MRI Pregnancy Physician concern regarding closure of AV fistula

Outcome results