SPIRONOLACTONE and EPLERENONE - Therapeutic Potential for Aldosterone Inhibition in Duchenne

Frequently Asked Questions (FAQs) about this research:

 

What stage is this research?

  • This Phase 3 trial is active, but no longer recruiting participants.  

 

What is the goal or purpose of this research?

  • The purpose of the study is to compare the effect on heart and lung function of 2 available generic drugs used for other conditions. We will see if spironolactone works just as well as eplerenone, which was previously shown to be effective in boys with Duchenne.

 

Who is sponsoring this research?

  • This study is sponsored by the National Institutes of Health.  

 

Who was eligible to participate in this study?

  • Participants must be males with Duchenne, at least 10 years old, able to have an MRI scan and not taking eplerenone or spironolactone. Please see www.ClinicalTrials.gov for additional inclusion and exclusion criteria.  

 

 What will participants do in this study?

  • Participants will be randomly assigned to receive either eplerenone or spironolactone, and they will take one tablet of the assigned drug once daily for 12 months.
  • All participants will have blood drawn at the baseline visit as well as months 1, 2, 3, 6, 9 and 12.
  • All participants will have a cardiac MRI scan and pulmonary function tests at baseline and 12 months.  

 

Where does this study take place?

  • The baseline visit will take place at one of the following:Blood draws at 1, 2, 3, 6, and 9 months can be done at a local laboratory where you reside.
    • The Ohio State University (OSU) in Columbus, OH
    • Mattel Children's Hospital in Los Angeles, CA
    • University of Colorado Hospital in Aurora, CO
    • University of Utah Hospital in Salt Lake City, UT
  • The 12 month visit will be done at the same site where you had your baseline visit. 

 

When can we expect results from this study?

  • Research estimate that results from this study will be available at the end of 2018.

 

Where can I learn more about this study?

  • You can learn more about this study at www.ClinicalTrials.gov (NCT02354352)
  • You may also contact:
    • Dr. Subha Raman at The Ohio State University, (614) 688-8020 or This email address is being protected from spambots. You need JavaScript enabled to view it.
    • Dr. Nancy Halnon at Mattel Children's Hospital, (310) 267-7618 or This email address is being protected from spambots. You need JavaScript enabled to view it.
    • Dr. Scott Auerbach at University of Colorado, (720) 777-8723 or This email address is being protected from spambots. You need JavaScript enabled to view it.
    • Dr. Michael Puchalski at University of Utah, (801) 587-9104 or This email address is being protected from spambots. You need JavaScript enabled to view it. 

(Updated 5/11/2017)