Marfan Syndrome (MFS) Medication Study

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

Marfan Syndrome (MFS) Medication Study

Description

What is the purpose of this study?
This study will compare the effect of beta blocker therapy (Atenolol) to that of angiotensin II receptor blocker therapy (Losartan) on the rates of aortic growth and other cardiovascular outcomes.

What is involved? This study lasts for three years and includes six visits. The following is a list of procedures that will take place during the study:

  • Echocardiogram at the initial visit baseline, 6, 12, 24 and 36 month visits.
  • Blood work to check for safety at the first visit and at about 4 months
  • Phone conversation with a study nurse every 3 months

What are the benefits?
You or your child may or may not receive direct benefit from participating in this study comparing Atenolol or Losartan. The biggest benefit is that your child may be helping others with Marfan Syndrome. Clinical studies are essential in finding new and improved treatments.

Will I get all the facts about the study?
Parents and adult subjects will be given a consent form that thoroughly explains all of the details of the study. It includes all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns, and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until the parent/guardian or you, the participating study subject, have signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
Although people usually tolerate both Losartan and Atenolol well, there is the potential of side effects whenever you take medication. Both Atenolol and Losartan are approved by the FDA and are taken by both children and adults. A detailed list of side effects will be provided to those patients interested in knowing more about the study.

What is the pay?
Participants will be reimbursed for travel and lodging. All study related tests and medications will be paid for by the study. All adult participants and parents of minor participants will receive $25 after the first three visits and $100 for each of the subsequent three annual visits. Additionally, minor participants will receive $20 gift cards after each visit.

Who will be included in this study?
Children, adolescents, and young adults, age 6 months to 25 years, with MFS who have aortic root dilation may be eligible to participate.

Who will be included in this study?
Children, adolescents, and young adults, age 6 months to 25 years, with MFS who have aortic root dilation may be eligible to participate.

Details
Condition Cardiovascular Abnormalities
Clinical Study IdentifierTX134366
Last Modified on25 March 2021

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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