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Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
NCT02354352 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Spironolactone
- DRUG Eplerenone
Study Locations (6)
California
- Mattel Children's Hospital and David Geffen School of Medicine at UCLA — Los Angeles
Colorado
- University of Colorado — Aurora
Kansas
- University of Kansas Medical Center — Kansas City
Ohio
- The Ohio State University Medical Center — Columbus
Tennessee
- Vanderbilt University Medical Center — Nashville
Utah
- University of Utah — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2015-03-20 |
| Est. Completion | 2018-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02354352
The ClinicalTrials.gov registry entry for NCT02354352 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 640 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 2 interventions — of which Spironolactone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02354352 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Colorado, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02354352 about?
NCT02354352 is a clinical study titled "Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy". 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 ran...
What is the current status of trial NCT02354352?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2015-03-20. Estimated completion is 2018-05.
What conditions does trial NCT02354352 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02354352?
The interventions under investigation include: Spironolactone (DRUG), Eplerenone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02354352?
This trial is sponsored by Ohio State University, which has 640 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02354352 being conducted?
This trial has 6 study locations across California, Colorado, Kansas, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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