RecruitingNAINTERVENTIONAL

Fontan-Sprechstunde

This study is for people in the UK who have a 'univentricular heart' and have had Fontan surgery. While the surgery itself is usually successful, some people develop long-term problems like issues with their gut, liver, or heart. These can include protein loss, which can cause diarrhoea, and liver problems. We are collecting information from patients over time to better understand why these complications happen. By systematically looking at things like blood tests, heart function, and lifestyle, we hope to find ways to improve treatment and care for everyone with a Fontan circulation, helping them live healthier lives.

At a glance

Status

Recruiting

Phase

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

200

Start

01 Sep 2020

Estimated completion

01 Sep 2041

Univentricular Heart

What is this study about?

If you or someone you know has a 'univentricular heart' and has had Fontan surgery, you might be interested to hear about this study. Fontan surgery is a special operation for people born with a heart that only has one pumping chamber instead of two. While this surgery often works well in childhood, doctors have noticed that some people develop health problems later in life.

These long-term problems can include things like protein loss from the gut, which might lead to tummy upsets and swelling. The liver can also be affected, as can the heart itself, sometimes leading to irregular heartbeats or less effective pumping. This study aims to watch and learn from many patients who have had Fontan surgery.

By carefully collecting information over time, such as blood test results, heart scans, and details about physical activity and well-being, doctors hope to identify what factors might lead to these complications. Ultimately, this research is about finding better ways to care for people with a Fontan circulation, helping them stay healthier for longer and improving their quality of life.

Key takeaways

Aims to understand long-term health after Fontan surgery.
No new treatments, just careful observation and data collection.
Focuses on improving care for people with a Fontan circulation.
Participation involves routine visits and some extra tests.
You can withdraw at any time without affecting your care.

Who may be eligible?

This study is for people who have a specific type of heart condition from birth, where their heart essentially has only one main pumping chamber instead of two. You must have already had the special surgery called the Fontan procedure to correct this problem.

Participants need to be between 6 and 60 years old. Both males and females can take part in this study.

There are no specific conditions that would prevent you from joining, as long as you meet the age and heart condition requirements mentioned above. If you're unsure if you fit these criteria, it's best to speak with your doctor.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a heart condition called a 'univentricular heart'?
Have you had Fontan surgery?
Are you between 6 and 60 years old?
Are you happy for doctors to collect extra information during your regular check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your involvement will mostly happen during your routine visits to the hospital. On a few specific occasions, alongside your usual check-ups, some extra steps will be taken.

This will involve providing small blood samples, which will be taken at the same time as any routine blood tests you might have. These samples will help researchers look at changes in your immune system and other body chemicals. You might also be asked to fill out some questionnaires to understand how you are feeling, your social life, and any developmental aspects.

Researchers will also look closely at your liver and kidney scans, and assess your heart function and exercise ability. If appropriate, you might receive advice on physical activity, possibly including a personalised exercise plan. The total duration of your participation will depend on how long the study continues to collect information during your regular follow-up appointments.

Potential risks and benefits

Taking part in this study won't involve any new or experimental treatments. The main benefit is that by sharing your health information, you'll be helping doctors learn more about Fontan circulation, which could improve care for many patients in the future, including yourself. The risks are very low, as most procedures are part of your routine care, with only small extra blood samples taken. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Universitätsklinikum
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What is a 'univentricular heart'?

It's a rare heart condition present from birth where the heart essentially has only one main pumping chamber instead of the usual two.

What is Fontan surgery?

It's a special surgery to redirect blood flow when someone has a univentricular heart, helping the body get enough oxygen.

What kind of problems can happen after Fontan surgery?

Some people might develop issues with their gut (like protein loss), liver problems, or complications with their heart function over time.

Will I have to take new medicines?

No, this study doesn't involve giving you any new or different medicines. It's about collecting information during your regular care.

Who is running this study?

This study is being conducted by medical professionals who specialise in heart conditions, aiming to improve understanding and care for Fontan patients.

How to find out more

Isabelle Schöffl, PD

isabelle.schoeffl@uk-erlangen.de 09131 85 33750 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.