Frequently Asked Questions (FAQs) About This Study
What is the purpose of the study?
- To determine if eplerenone, a type of medication typically used for advanced heart failure patients, in combination with another medicine (ACE-I or ARB) can prevent heart muscle damage in people with DMD.
Who is eligible for the study?
- If you are a male with DMD, at least 7 years old and:
- no kidney problems
- not on eplerenone or other drugs like it
- can undergo a cardiac MRI scan without sedation and follow breathhold instructions
- have preserved left ventricular systolic function
How long will this study last?
- 12 months
How many study visits are there?
- After the initial (baseline) screening visit, there are five study visits during a 12-month period.
- The study visits will happen during months one, three, six, nine and 12.
Where do the study visits take place?
- The baseline visit will take place either at The Ohio State University (OSU) in Columbus, OH or Cincinnati Children’s in Cincinnati, OH.
- Blood draw at 1, 3 and 9 months can be done at a local laboratory where you reside.
- Visits 6 and 12 months are done at the same site where you did your baseline visit.
What will happen during this study?
- Participants will be randomly assigned to receive either eplerenone (the study drug) or a placebo. A placebo is an inactive substance that looks like the study drug, but contains no medication.
- Participants will take assigned drug every other day for one month.
- If after one month, levels of potassium and creatinine (marker of kidney function) are normal, participants will continue to take the drug once daily for the remainder of the study.
- All participants will have blood drawn at the baseline visit as well as during months 1, 3, 6, 9 and 12.
- All participants will have a cardiac MRI scan at the baseline, 6 and 12 months.
Is there payment for participation?
- There is no payment for participating in the study but you will be reimbursed for travel, food and lodging expenses upon completion of the 6 month visit.
- The blood draws during months 1, 3, 6 and 9 will be paid for by the study.
- The cardiac MRI scan at the 6 and 12 month visit will be paid for by the study.
- The study drug will be provided for free.
Will there be access to the drug once the study has ended?
- If the results are promising, your physician may choose to prescribe this medication to you or your child after the study has ended.
Why should I consider participating in this study?
- While no personal benefit can ever be guaranteed, there are other benefits to participating in a research study. You may be able to:
- play an active role in your own health care (or that of your child)
- gain access to new research treatments before they are widely available
- have access to medical specialists who may not normally be available
- help others by contributing to the better understanding and treatment of DMD-associated heart disease.
Where can I learn more about this study?
- You can learn more about this study at PPMD.com and/or ClinicalTrials.gov.
- You may also contact:
Dr. Subha Raman or Beth McCarthy at The Ohio State University, (614) 688-8020 or email@example.com
Dr. Kan Hor or Lani Relucio at Cincinnati Children’s, (513)803-1910 or firstname.lastname@example.org