Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01521546
• Date of registration: 26/01/2012
• Prospective Registration: Yes
• Primary sponsor: Subha Raman
• Public title: Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy E-SCAR DMD
• Scientific title: Early Treatment With Aldosterone Antagonism Attenuates Cardiomyopathy in Duchenne Muscular Dystrophy
• Date of first enrolment: February 2012
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01521546
• Study type: Interventional
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Subha V Raman, MD, MSEE
• Affiliation: Ohio State University

Key inclusion & exclusion criteria

Inclusion Criteria:

- DMD patients age 7 years and older (and able to complete cardiac MRI without sedation)
with preserved left ventricular (LV) systolic function and abnormal heart muscle by
late post-gadolinium imaging (LGE)

Exclusion Criteria:

- renal insufficiency (GFR <40 mL/min/m2)

- non-MR compatible implants (e.g. neurostimulator, AICD)

- severe claustrophobia

- allergy to gadolinium contrast

- prior use of or known allergy to epleronone

- use of potassium-sparing diuretics

- serum potassium level of >5.0 mmol/L



Age minimum: 7 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Duchenne Muscular Dystrophy

Intervention(s)

Drug: eplerenone

Drug: placebo

Primary Outcome(s)

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

Secondary ID(s)

2011H0251

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ballou Skies

Results

• Results available: Yes
• Date Posted: 27/05/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01521546