RecruitingNAINTERVENTIONAL

Prospective Evaluation of Univentricular Hearts

This study focuses on children born with a serious and rare heart condition called a "univentricular heart." This condition means the heart doesn't pump blood in the usual way, often requiring a series of three operations during early childhood, leading to something called a "Fontan circulation." These operations are complex, and sadly, there's a higher risk for these children before the Fontan circulation is fully working. The study evaluates a specific, detailed treatment plan that was developed in Erlangen, Germany. This plan involves various heart checks, like special scans (MRI) and internal heart pictures (cardiac catheterization), as well as blood tests, done at set times before and after operations. The main aims are to understand each child's specific risks, tailor their treatment, and find any problems early. This approach helps doctors give the best possible care to children with this challenging heart condition.

At a glance

Status

Recruiting

Phase

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

Start

20 May 2021

Estimated completion

20 May 2041

Univentricular Heart

What is this study about?

Imagine your heart usually has two separate pumps that work together – one for sending blood to your lungs and one for sending blood to your body. Children with a "univentricular heart" condition are born with only one main pumping chamber. This is a very complex condition that means their heart can't work in the usual way.

To help their heart work better, these children typically need a series of three major operations, usually within their first few years of life. These surgeries gradually change how blood flows through their heart, eventually creating something called a "Fontan circulation." This new circulation system allows the single pumping chamber to focus on sending blood to the body, while the blood from the body flows directly to the lungs without needing a separate pump. It's a life-saving process, but it's very challenging for these young patients and can carry significant risks until the Fontan circulation is established.

This study is looking at a specific and detailed treatment plan that has been used in a hospital in Erlangen, Germany, since 2008. This plan involves careful monitoring and checks before and after each operation. These checks include advanced scans, like MRI (which uses magnets to create detailed pictures of the heart) and sometimes a procedure called a cardiac catheterization (where a thin tube is guided into the heart to take measurements and pictures). They also do blood tests and other non-invasive checks. The main goal of this structured approach is to understand each child's heart condition very precisely, identify any potential problems or complications early, and make sure their treatment is tailored perfectly to their individual needs. By doing this, doctors hope to improve the chances of a successful outcome and help these children live as well as possible.

Key takeaways

This study explores a structured treatment plan for children with a serious heart condition called a "univentricular heart."
It involves detailed heart assessments, including MRI scans and sometimes cardiac catheterization, before and after a series of operations.
The aim is to improve care by adapting treatment, assessing risks, and finding potential problems early.
The study evaluates a specific approach that has been used in Germany with positive results.
It focuses on patients who need the "Fontan procedure," a series of operations for this heart condition.

Who may be eligible?

This study is looking for children and young adults born with a specific type of complex heart condition called a "univentricular heart." This means they were born with a heart that has only one main pumping chamber, rather than the usual two.

To be considered for the study, a person must need the series of operations leading to the "Fontan procedure" as part of their medical care. This clinical trial is designed for individuals aged between 6 and 60 years old and is open to both males and females.

There are no specific reasons listed that would prevent someone from joining the study if they meet the criteria for having a univentricular heart and needing the Fontan procedure.

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.

Were you, or your child, born with a univentricular heart (only one main pumping chamber)?
Is the Fontan procedure (a series of heart operations) part of the recommended treatment plan?
Are you, or your child, between 6 and 60 years old?
Are you healthy enough to undergo the procedures and follow-up tests involved?

Answer every question to see your result.

What does participation involve?

Taking part in this study means following the specific diagnostic and treatment plan developed at Erlangen. This involves undergoing several check-ups, including heart scans (MRI) and sometimes a procedure called cardiac catheterization. These checks happen before and after your child's heart operations. There will also be regular blood tests and other non-invasive examinations. The final heart MRI scan is scheduled six months after the last major operation (the Fontan operation). If an MRI isn’t possible, or if doctors spot certain issues, they might recommend a cardiac catheterization within the first year after the Fontan operation. The overall duration encompasses the entire treatment journey, from initial diagnosis through the series of operations and follow-up checks until at least six months after the Fontan operation.

Potential risks and benefits

Participating in this study means your child will receive care under a very well-defined and structured plan, which has shown to be helpful in guiding individualized treatment and potentially identifying complications earlier. This might lead to better tailored care. However, it's important to remember that the heart condition itself is very serious, and while the study aims to improve outcomes, there are inherent risks associated with complex heart surgeries and medical procedures. Some diagnostic tests, like cardiac catheterization, are invasive and carry their own small risks, including infection or bleeding. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your child's standard medical care.

Locations (1)

Universitätsklinikum
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What is a univentricular heart?

It's a serious heart condition where a baby is born with only one main pumping chamber in their heart, instead of the usual two.

What is a Fontan circulation?

This is a special way blood flows through the heart after a series of operations, allowing the single pumping chamber to work more effectively.

What kind of tests are involved?

The study includes various heart checks like MRI scans (detailed pictures of the heart), sometimes cardiac catheterization (a procedure where a thin tube is guided into the heart), and blood tests.

Why is this study important?

It helps doctors understand how best to treat children with this complex heart condition, aiming to improve their care, spot problems early, and give them the best chance for a healthy life.

How long does a child participate in the study?

Participation covers the entire treatment journey, from initial diagnosis through the series of operations and follow-up checks until at least six months after the final Fontan operation.

How to find out more

Sven Dittrich, Prof.

sven.dittrich@uk-erlangen.de 09131 85 33750 Official trial record

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