MedTrace Logo

Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy

NCT02354352 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-10-07

Study results available
· View outcomes & findings →

Summary

The study is to demonstrate non-inferiority of spironolactone vs. eplerenone in preserving cardiac and pulmonary function in patients with preserved LV ejection fraction. Males with Duchenne muscular dystrophy (DMD) confirmed clinically and by mutation analysis will be enrolled. Subjects will be randomized to either eplerenone or spironolactone. Subjects will use a drug diary to record daily compliance of taking the study medication as well as any concerns they may have during the study period. Subjects will undergo cardiac magnetic resonance imaging (CMR) and pulmonary function tests (PFT) at baseline and then again at 12 months post enrollment. Subjects will also complete a quality of life questionnaire at baseline and 12 months. Degree of elbow contracture will be measured using a goniometer at baseline and 12 months.

Conditions

Interventions

DRUG

Eplerenone

26 Subjects will take Eplerenone, one 50mg capsule by mouth once daily for 12 months.

DRUG

Spironolactone

26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months.

Sponsors & Collaborators

  • University of California, Los Angeles

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • University of Kansas Medical Center

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • Subha V Raman, MD · 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
2015-03-20
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02354352 on ClinicalTrials.gov