Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Theophylline Effects in the Fontan Circulation

This research is investigating a medication called Theophylline for adults who have undergone the Fontan procedure for a complex heart condition (univentricular congenital heart disease). The main goal is to check how safe Theophylline is for these patients. We'll be carefully looking for any side effects and seeing if people can take the medicine without too much trouble. We also want to understand if it helps improve how much oxygen their body can use during exercise, which is a sign of how well their heart is working. Additionally, the study will explore if it can boost their overall quality of life and heart function. This is an early-stage study, meaning we are exploring these effects for the first time in this group.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Oslo University Hospital Hf

Enrolment target

Start

21 Sep 2022

Univentricular congenital heart disease with a Fontan-type surgical palliation

What is this study about?

This study is exploring a medicine called Theophylline for adults who have a special type of heart condition. These individuals were born with a heart that didn't form completely, having only one main pumping chamber instead of two. To help their heart work better, they underwent a major operation called the Fontan procedure. While this surgery is lifesaving, many patients still face challenges, such as feeling tired or out of breath, and their heart may not always pump as strongly as it should.

We want to see if Theophylline can make a difference for these patients. Theophylline is a medication that has been used for other conditions, but we're now investigating if it can help improve the way the heart and lungs work together specifically for people with a Fontan circulation. The hope is that it might help them feel better and improve their ability to do daily activities.

The main focus of this study is to make sure Theophylline is safe for people with a Fontan heart. We will be carefully monitoring for any unwanted effects. We'll also be looking closely at how well participants can tolerate the medicine. If it proves to be safe, we will then explore if it can help their body use oxygen more effectively when they exercise, which is a good way to measure overall heart and lung fitness. We'll also be checking their quality of life, how well their heart muscle is working, and even how they breathe during sleep.

Key takeaways

This study investigates if Theophylline is safe and helpful for adults with a Fontan heart.
It aims to improve heart and lung function and general wellbeing.
Participation involves taking medication and attending regular health checks.
Your safety is the top priority, and all potential side effects will be closely monitored.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults are also welcome to participate.

This study is for both men and women. We want to include a wide range of people to get a complete picture of how the medicine works.

Importantly, you must have been diagnosed with a specific heart condition called univentricular congenital heart disease and have already had the Fontan operation. This study is specifically designed for people who have gone through this particular surgical 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.

Are you 18 years old or older?
Have you been diagnosed with univentricular congenital heart disease?
Have you previously had a Fontan operation?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be taking a medication called Theo-Dur 200mg (a slow-release tablet of Theophylline). You would need to take this medicine regularly as instructed. Throughout the study, you'd have several clinic visits where doctors and nurses would monitor your health very closely. They would conduct various assessments, such as checking your heart function with scans (like an echocardiogram), measuring how well you use oxygen during gentle exercise, and asking you to fill out questionnaires about how you feel and your quality of life. You might also have a sleep study at home to check your breathing during sleep. There would be regular blood tests to check the level of the medicine in your body and to monitor your general health. The total duration of your participation in the study, including all follow-up visits, would be explained to you in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a chance to improve how your body uses oxygen and potentially feel better overall. However, like all medications, Theophylline can have side effects. These could include things like headaches, nausea, or a fast heartbeat, which the study team will monitor closely. There's also a chance the medicine might not help you. Your safety is our priority, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is Theophylline?

Theophylline is a medicine that has been used to help people with breathing problems. In this study, we are exploring if it can help the heart and lungs work better together for people with a Fontan circulation.

What is a 'Fontan circulation'?

A Fontan circulation is a special way the blood flows in someone who has had a major heart operation called the Fontan procedure. This surgery helps people born with only one main pumping chamber in their heart.

Will I know if I'm getting the study medicine or a dummy pill?

The study design will be explained to you by the research team. Sometimes in studies like this, participants are given the actual medicine or a placebo (a dummy pill) to fairly compare the effects. You would be told which group you are in at the end of the study.

What kind of tests will I have?

You might have tests like heart scans (echocardiograms), breathing tests, exercise tests to measure oxygen use, and blood tests. You'll also be asked to fill out questionnaires about your health and wellbeing.

How long will I be in the study?

The exact length of your participation will be discussed in detail by the study team, including how many visits you would need and for how long. It's important to understand the full commitment before joining.