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Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy

NCT01521546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-11-08

Study results available
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Summary

Duchenne muscular dystrophy (DMD), the most common muscular dystrophy, leads to skeletal and cardiac muscle damage. Treatment of pulmonary complications has improved survival; however, heart muscle disease or cardiomyopathy has emerged as a leading cause of death, typically by the third decade. Although myocardial changes begin early, clinically significant heart disease is rarely detected in the first decade of life. Consequently, DMD cardiomyopathy frequently goes unrecognized (and untreated) until advanced (and irreversible).

Current DMD cardiovascular care guidelines recommend beta-blockers and angiotensin converting enzyme inhibitors (ACEIs) when decreased ejection fraction (EF) is noted by echocardiography (echo); however, this strategy has not significantly improved outcomes. Our team has recently made a breakthrough in a mouse study, showing in a model that causes the same heart muscle disease in humans with DMD adding an old medicine traditionally used for high blood pressure and late-stage heart failure can actually prevent heart muscle damage. Because of this drug's proven safety in both children and adults, it is ready to be studied immediately in an RCT in patients with DMD to hopefully show, as we did in mice, that we can prevent the devastating consequences of heart muscle damage.

Conditions

Interventions

DRUG

eplerenone

25mg tablet, once daily by mouth for 12 months

DRUG

placebo

one tablet by mouth daily for 12 months

Sponsors & Collaborators

  • Ballou Skies

    collaborator OTHER

  • Subha Raman

    lead OTHER

Principal Investigators

  • Subha V Raman, MD, MSEE · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01521546 on ClinicalTrials.gov