Who can participate in this trial?

Key Inclusion Criteria:

  • Males and females with Fontan physiology

  • 12-18 years of age

  • Current antiplatelet or anticoagulant therapy, including asprin

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What’s Involvement Like?

  • The study will last for up to 7 months

  • Visits to a study center for tests and to check your health once before the study begins and again throughout the course of the study

  • Phone call check-ins throughout the study period

Key Exclusion Criteria

  • Height less than 4 ft. 4 in.

  • Peak VO2 <45% or ≥80% of that predicted for age and gender.

  • Use of PDE5 inhibitors within 12 months or other pulmonary hypertension medication within 3 months.

  • Hospitalization for acute decompensated heart failure within the last 12 months.

  • Undergoing evaluation or listed for heart transplantation.

Compensation for Participation

  • Qualified participants may be compensated up to $515 in addition to coverage of all travel-related expenses such as airfare, lodging, gas, etc.

  • Insurance is not required for participation in the trial and will not be billed for participating.

What will happen during the study?

Before taking medication:

  • If you decide to join the study, you will have a visit at the study center to check if the study is right for you.

  • The study doctor will want to know more about you and your condition. They will also do some tests to check your health.

  • If the study is right for you, you will receive an electronic diary (or eDiary) to record when you take the study medicine.

When taking study medication:

  • You will have to take the study medicine as instructed, twice a day every day, for 6 months.

  • The study team will regularly check on how you are doing and if you are taking the study medicine correctly. They will call you by phone:

    • 4 times, for the first month of the study – meaning you will have a phone call once a week.

    • Then another 5 times, until you stop taking the study medicine – meaning you will have a phone call once a month.

  • At the end of this period, you will have to come back to the study center for some health checks.

After taking medication:

  • The study team will call you, your parents, or the person looking after you by phone. This telephone call is to check if you had any changes in your health or had to take new medicines.

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FAQs

  • Before new medicines can be used to treat people, doctors must make sure that the medicines work and are safe. To do this, they test the new medicines in clinical research studies, with the help of other doctors and scientists.

  • This is a study to test a new medicine for teenagers with a heart condition called single ventricle heart disease.

    The study doctors are looking at a possible new medicine, called udenafil. This medicine could help children and teenagers who had the Fontan procedure have more energy.

    Udenafil works by relaxing the blood vessels and improving blood flow to the lungs. This way your blood oxygen levels are higher, and you may be less tired when exercising or during everyday activities.

    In this study, we want to find out how well udenafil works to improve your ability to exercise and do your daily activities. We also want to know how safe udenafil is for teenagers with single ventricle heart disease. who had the Fontan procedure.

  • Single ventricle heart disease is a medical condition that some babies are born with. A heart usually has 4 chambers: 2 atria and 2 ventricles. In single ventricle heart disease., the heart has only 1 ventricle. The ventricles are the main pump for the heart. They send blood out to the lungs and the rest of the body.

    Most people with single ventricle heart disease need to have multiple surgeries when they are babies to help their heart work better. One of those surgeries is called the Fontan procedure. It is done to direct the blood to the lungs instead of the heart.

    Even after the Fontan procedure, the heart must work harder to pump enough blood and oxygen around the body. This can make it harder for children and teenagers with SVHD to do physical activities that require a lot of effort, like playing intense sports or doing challenging exercises. For this reason, you may also need to take medicines to help improve your blood flow.

  • There are different medicines to help improve your blood flow. However, some of these medicines cannot be given to teenagers or do not work the same for everyone.

    This is why it is important to research new medicine options for teenagers who had the Fontan procedure.

    We hope that what we learn in this study may help doctors treat other teenagers with single ventricle heart disease. who had the Fontan procedure in the future.

  • You will not be alone! More than 400 teenagers with single ventricle heart disease who had the Fontan procedure, just like you, will be invited to take part in this study.

  • In this study, you will be placed by chance (like flipping a coin) in 1 of 2 groups. Depending on which group you are placed in, you will receive:

    • udenafil (the study medicine), twice a day

    • a placebo, twice a day

    The placebo is a “dummy medicine.” This means that it looks just like the study medicine but contains no active medicine. Both udenafil and the placebo can be called the “study medicine” from here on. You, your parents (or the person looking after you), and the study doctor will not know which study medicine you will receive. You will have the same chance of receiving either udenafil or the placebo.