Fontan Follow-Up 3

(Completed Recruiting)

About This Study

This is a second follow-up study of an existing cohort of children from the Fontan 1 Study. In this study we would like to learn how these teens and young adults, who are now between the ages of 15 and 25 years, have done since their enrollment in Fontan 1.

Study Locations

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Study Details

The Fontan 3 study is a second follow-up study of an existing cohort of children, originally between 6 and 18 years at time of enrollment in the Fontan Cross-Sectional (Fontan 1) Study between March 2003 and April 2004. In this study we would like to learn how these children and young adults, who are now between the ages of 15 and 25 years, have done since their enrollment in Fontan 1. The study began in June, 2012 and all children who were enrolled in the Fontan study were invited to participate.

You can be in the study if you were enrolled in the Fontan 1 Cross-Sectional study, or the Fontan 2 study.

The study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to sign an informed consent form to enter the study.

This is what needs to be done in the study:

  • Medical Record Review: We will contact you and look at your medical chart to obtain information about surgeries, tests or times that you were in the hospital. We will also ask if you are taking medicine or getting services like physical or speech therapy. You may be asked to sign a form allowing us to get information from other places where you have received or are receiving care.
  • Echocardiogram: We will have you take a painless test using sound waves that takes a 2-dimenstional picture of your heart. You will need to lie quietly on a table for about 30 minutes while the test is being done.
  • Exercise Testing: You will be asked to do an exercise test. If you are a female able to have children, you will be asked to have a urine or blood pregnancy test. If you are pregnant, you will not be asked to take the exercise test. This test will be done to see how your heart functions. Before the test, you will have a lung function test. A standard ECG will be done and blood pressure will be taken. You will be asked to pedal on a stationary bike. During this time, various measurements of breathing, heart rate and blood pressure will be taken.
  • Blood Sample: A small needle will be placed into a vein and approximately, 1 teaspoon (5 mL) of blood will be drawn from the needle.
  • Questionnaires: Depending on your age, we will ask you or both you and one of your parents to complete questionnaires about yourself. Some of these questionnaires will be completed in a telephone interview. Others will be mailed to your home for you or one of your parents to fill out. The questionnaires will ask about physical, emotional, and social aspects of your health and about your quality of life. The questionnaires will also ask about your living situation, education, work outside the home, and other factors, such as health insurance coverage, that may affect your medical care.

Study personnel will be in contact with you during the time you are in the study. You are free to call the nurse or study coordinator at any time with any questions or concerns that you may have.

After you enroll and complete the questionnaires, we will continue to review your medical records and may also contact you once a year, by a brief telephone call or letter, for up to 10 years to see how you are doing. In addition, study personnel will keep you informed about other possible follow-up studies. However, you are not committed to entering any other studies.

The questionnaires will provide information about how you act and function, which might not otherwise be known. If problems are found, early help can be suggested. We will be able to determine how your heart is functioning through the use of the tests described above. The results of all tests performed as part of the study will be made available to you through your cardiologist. You may not benefit directly from being in this study, but the information we learn from this study may help improve the care of other children and young adults who have also been born with a heart defect.

You may find it inconvenient to complete the questionnaires or to talk with the study nurses by telephone. You do not have to answer any questions that make you feel uneasy. Study nurses will be willing to answer questions or provide support as you complete the questionnaires. Risks associated with drawing blood include momentary discomfort and/or bruising. Infection, excess bleeding, clotting, or fainting are also possible, although unlikely. There are no risks associated with echocardiography. Exercise testing involves trying to exercise as hard as you can. A small number of individuals who have had a Fontan operation develop an abnormal heart rhythm with strenuous exercise. Monitoring the heart’s rhythm during the test will tell us whether this occurs and will help us learn how to care for you. A member of the exercise testing team will be present throughout the test to continuously monitor your heart rhythm and how you are doing.

There will be no extra costs to you when you join this study. You must pay for all other costs related to your normal medical care such as hospital stays, surgery, drugs, lab tests, and doctor’s fees which are thought to be standard medical care for patients with your condition.