Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy (E-SCAR DMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01521546
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : May 27, 2015
Last Update Posted : November 8, 2016
Ballou Skies
Information provided by (Responsible Party):
Subha Raman, Ohio State University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Duchenne Muscular Dystrophy
Interventions: Drug: eplerenone
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment was required prior to assignment.

Reporting Groups


placebo: one tablet by mouth daily for 12 months


active study drug

eplerenone: 25mg tablet, once daily by mouth for 12 months

Participant Flow:   Overall Study
    Placebo   Eplerenone
STARTED   22   20 
COMPLETED   20   20 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Males with Duchenne Muscular Dystrophy

Reporting Groups

active study drug

eplerenone: 25mg tablet, once daily by mouth for 12 months



placebo: one tablet by mouth daily for 12 months

Total Total of all reporting groups

Baseline Measures
   Eplerenone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   22   42 
[Units: Years]
Median (Inter-Quartile Range)
Age   14.5 
 (12.0 to 18.5) 
 (11.0 to 19.0) 
 (11.75 to 19.0) 
Gender [1] 
[Units: Participants]
Female   0   0   0 
Male   20   22   42 
[1] The study was approved for 42 participants and 42 participants were enrolled.

  Outcome Measures

1.  Primary:   12-month Change in Myocardial Strain   [ Time Frame: baseline and 12 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Subha V. Raman, MD
Organization: The Ohio State University
phone: (614)293-8963

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Subha Raman, Ohio State University Identifier: NCT01521546     History of Changes
Other Study ID Numbers: 2011H0251
First Submitted: January 26, 2012
First Posted: January 30, 2012
Results First Submitted: April 21, 2015
Results First Posted: May 27, 2015
Last Update Posted: November 8, 2016