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NCT01521546 · ClinicalTrials.gov registry record · NA

Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy

A NA study of Duchenne Muscular Dystrophy, sponsored by Subha Raman.

Completed
Registry status
NA
Development phase
42
Enrollment target
3
Study locations

NCT01521546 is a NA study of Duchenne Muscular Dystrophy that has completed, run by Subha Raman. The registered enrollment target is 42 participants, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT01521546, a NA study of Duchenne Muscular Dystrophy, has completed, sponsored by Subha Raman.

COMPLETED
Registry status
NA
Development phase
42 participants
Enrollment target
3
Study locations

Study 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 Studied

Duchenne Muscular Dystrophy

Interventions

  • DRUG placebo
  • DRUG eplerenone

Study Locations (3)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati
  • The Ohio State University Medical Center - Columbus

California

  • Mattel Children's Hospital and David Geffen School of Medicine at UCLA - Los Angeles

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2012-02
Est. Completion 2016-06
Phase NA

Sponsor

Subha Raman

2 total trials

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What the Registry Record Tells You About NCT01521546

The ClinicalTrials.gov registry entry for NCT01521546 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (90% lower). The listed sponsor is Subha Raman, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT01521546 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Ohio, California.

Frequently Asked Questions

What is clinical trial NCT01521546 about?

NCT01521546 is a clinical study titled "Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy". 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. Alth...

What is the current status of trial NCT01521546?

This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2012-02. Estimated completion is 2016-06.

What conditions does trial NCT01521546 study?

This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.

What interventions are being tested in trial NCT01521546?

The interventions under investigation include: placebo (DRUG), eplerenone (DRUG).

Who is sponsoring clinical trial NCT01521546?

This trial is sponsored by Subha Raman, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01521546 being conducted?

This trial has 3 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.