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Research Projects & Clinical Trials

Fontan Transition to Adult Healthcare
- Closed 2019 - Analysis in Process 2019

Through an NHMRC Partnership Grant, we are currently recruiting young people with a Fontan circulation and their parents to take part in a transition study which involves completing short surveys.


This study is running at Royal Children's Hospital (Melbourne), at the Children's Hospital at Westmead (Sydney), and at the Women's and Children's Hospital (Adelaide). It looks at young people and their parents/carers' experiences of transition to adult healthcare.


 For more information and to register your interest, please email: 

Fontan Functional Outcomes:
 Closed end 2017

This study funded by an NHRMC Project Grant recruited individuals aged 13 years+ with a Fontan circulation in a Melbourne, Sydney and Auckland based study.


This study looked at the impact of blood thinning medication and fenestration on bone density, heart and brain function, exercise capacity, and quality of life. We are currently compiling and analysing data.


This project will generate a huge number findings! We hope to share some of the preliminary data at our Fontan Education Day 2018 in Adelaide.


We are extremely grateful for all the wonderful support from all our participants across Australia and New Zealand who helped with this project.

A HUGE thank you to all involved!!

  • Sofia talking about the MRI component
  • Kathryn talking about Echocardiogram,
  • Bone Density and Brain MRI 
  • A participant's experience: Brian Rose
FAN Clinical Trial - Recruitment on hold 2020 Identifier: 

Through the Australian and New Zealand Fontan Registry, we are running a randomised control trial which assess the effect of perindopril on Fontan-Associated Nephropathy (FAN).  Approximately, one third of people with Fontan circulation have early signs of kidney damage without any symptoms.  We are doing this study to find out if taking a drug called perindopril for 6 months can treat this kidney damage. 


The study will screen those with Fontan circulation (>5years of age) for early signs of kidney disease by obtaining a urine sample.  Only those with signs of kidney disease will be invited to participate in the treatment phase of the study.  The treatment phase with randomize participants into one of the two groups.  Group 1 will be taking the drug perindopril and be compared to group 2 who will be taking a placebo (sugar) pill.  Perindopril is a drug known as an angiotensin converting enzyme (ACE) inhibitor which lowers blood pressure.   Participation in the treatment phase will require 4 hospital visits over an 8 month period; baseline, week 2, week 6 and then 7.5 months.   The visits will include clinical assessments (all visits), blood and urine samples (all visits) and a nuclear medicine evaluation of kidney function referred to as glomerular filtration rate (GFR) (baseline and final visit).  Please take a moment to watch this short video about the study.

This is a multi-centre study; Royal Children’s Hospital (currently recruiting children and adults), The Children’s Hospital at Westmead (forthcoming) and Royal Prince Alfred Hospital (forthcoming).


The principal investigator for this project is Prof Yves d’Udekem. 


For more information please contact:

Rubato Clinical Trial - Recruitment completed and ceased July 2020 Identifier: NCT03153137

Through the Australian and New Zealand Fontan Registry, we are running a randomised controlled trial which is sponsored by Actelion (a Janssen Pharmaceutical Company of Johnson & Johnson). 


This is a prospective, multi-center, double-blind, randomised, placebo-controlled parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. Recruitment is done through individual sites around Australia and New Zealand, and includes consultation with your treating cardiologist before investigators contact potential participants. 

For full details about the trial, visit:

ACE inhibitor cessation Trial - Recruitment on hold 2020

Trial ID: ACTRN12618000204246

Through the Australian and New Zealand Fontan Registry, we have initiated a randomised controlled trial which examines the effect of ACE (Angiotensin Converting Enzyme) inhibitors cessation on cardiac function in the setting of well-functioning Fontan hearts. 

Evidence has shown ACE inhibitors are of benefit in a failing 2-ventricle heart, but there is no literature to suggest they are of benefit in the Fontan circulation. This project aims to demonstrate that cessation of ACE inhibitors, or closely related angiotensin receptor blockers (ARB), is safe and non-inferior to ACEI/ARB continuation in children and adults with a Fontan circulation with good cardiac systolic function and without other indications for continuation such as moderate or greater valvar regurgitation and/or hypertension. Key inclusion criteria include: (1) having a Fontan circulation, (2) are taking ACE inhibitors or ARB medication for 12 months or more, and (3) can perform a cardiopulmonary exercise test on a cycle ergometer. The minimum age is 8 years of age. The intervention group will cease their ACEI or ARB medication for 12 months. The control group will continue taking their current ACEI/ARB medication in the dose and frequency that they have been prescribed by their treating medical practitioner. Participation also involves coming in to the treating hospital on 4 occasions (baseline, 1 month, 6 months, 12 months) to collect data on echocardiogram (baseline, 6 months, 12 months), cardiopulmonary exercise test on a cycle ergometer (baseline and 12 months), clinical assessment (baseline, 1 month, 6 months and 12 months), a blood test and urine sample (baseline and 12 months) and a few short questionnaires (baseline and 12 months).

Recruitment is done through individual sites around Australia and New Zealand: Royal Children's Hospital (currently recruiting), The Children's Hospital at Westmead (forthcoming), Royal Prince Alfred Hospital (forthcoming), Lady Cilento Children's Hospital (forthcoming), Starship Hospital (forthcoming). Recruitment includes consultation with your treating cardiologist before investigators contact potential participants. This project is supported with funding through the HeartKids Grants-in-Aid Scheme.

The Principal Investigator for this project is Prof Yves d'Udekem. For more information, please contact:

For full details about the trial, click here 

Liver and Kidney Function study 
Data collection complete -
Closed - Analysis in process - Publication in process 2018/19

We have now completed recruitment for the Liver and Kindney Function study funded through an NHMRC Project Grant. 


Thank you very much to all the participants and their families who supported us in gathering data for this project.


We are currently analysing the data. Watch this space for further information about the findings.

Early results video:  Click here

FROM THE HEART - Closed - Analysis in Process

It's not too late to be part of this important study! --> see the video introduction to this study by clicking here

For many of you, it‘s school holidays! Enjoy and have lots of fun. And for those of you who have started back at work or school this week, we hope you had a wonderful time over the break! If you’re on holidays or back into the swing of things, now is an ideal time to fill in your From the Heart surveys.


From the Heart is an Australia and New Zealand Fontan Registry research study open to children, young people and adults with a Fontan circulation, and their parents and siblings.


If you or your child are a part of the ANZ Fontan Registry and would like to know more about how to participate in this study, please contact Kate Marshall on 1800 025 509 (free call from anywhere in Australia) or send an email to:

You can also download our 2017 newsletter here


Kate and the 'From the Heart' study team

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