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Find Another Clinical Study

Research Study for Males 7 Years or Older with Duchenne Muscular Dystrophy: Investigational Drug for the Early Treatment of Cardiomyopathy in DMD

What is the purpose of this study?

The purpose of this study is to determine if eplerenone, a type of drug typically used for advanced heart failure patients, can slow down heart muscle damage in people with Duchenne Muscular Dystrophy (DMD).

Who can participate?

You may be able to participate in this study if you are a male with DMD, at least 7 years old and:

Do not have kidney failure
Do not currently take eplerenone or other drugs like it
Are able to undergo a cardiac magnetic resonance imaging (CMRI) scan without sedation
Are on or will be on a medication (ACE inhibitor or ARB) to manage your heart fibrosis
Your recent cardiac MRI shows scar tissue in your heart but your heart function is still normal.
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Conditions

Cardiology/Heart

What is involved?

If you choose to participate, you will be in the research study for 12 months and be asked to complete a screening, or baseline, visit along with 5 study visits.

The baseline visit, where we will screen and enroll you, occurs during your regular clinic visit at Cincinnati Children’s
Visits during months 1, 3 and 9 are done at a local laboratory near you
Visits during months 6 and 12 are done at Cincinnati Children’s

You will be randomly assigned to receive either eplerenone (the study drug) or a placebo (an inactive substance that looks like the study drug but contains no medication) and will take your assigned drug every other day for 1 month.

After that first month is over, you will then take the drug every day. However, you will need to have your levels of potassium and creatinine (markers of kidney function) checked at a local laboratory near you within a week of the dose change. If your results are normal, you will continue to take the drug on a daily basis for the remainder of the study.

You will also be asked to complete some health-assessments and medical tests, including:

Review of your medical and medication history
Physical exams
Pulmonary function test, if applicable
Cardiac MRI scans
Blood draws

A detailed list of procedures will be provided to anyone interested in knowing more about this study.

This study is also occurring at the Ohio State University (OSU) in Columbus, Ohio.

What are the benefits?

You may or may not receive a direct medical benefit from being in this study. However, the information gained from this study may help researchers understand more about DMD and develop new tests or medications to help others in the future.

Will I get all the facts about the study?

You will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, 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.