Trial · NCT01521546
Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy
NCT01521546, Not applicable, Completed, Subha Raman; results first posted 2015-05-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy. Trials, record NCT01521546. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01521546
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy
- NCT number
- NCT01521546
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 42 participants, actual
- Lead sponsor
- Subha Raman
- Conditions
- Duchenne Muscular Dystrophy
- Interventions
- eplerenone, placebo
- First posted
- 2012-01-30
- Last updated
- 2016-11-08
- Results first posted
- 2015-05-27
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 12-month Change in Myocardial Strain | baseline and 12 months | a sensitive measurement of heart function using cardiac MRI, change was 12 months minus baseline. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 12-month Change in Myocardial Strain | baseline and 12 months | percent change in heart dimension | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 12-month Change in Myocardial Strain | Placebo | 2.2 | Inter-Quartile Range 1.3 to 3.1 | percent change in heart dimension | |
| 12-month Change in Myocardial Strain | Eplerenone | 1.0 | Inter-Quartile Range 0.3 to 2.2 | percent change in heart dimension |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | STARTED | Eplerenone | 20 | |
| Overall Study | COMPLETED | Placebo | 20 | |
| Overall Study | COMPLETED | Eplerenone | 20 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Eplerenone | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | flushing | Skin and subcutaneous tissue disorders | Placebo | 1 | 22 | |
| other | flushing | Skin and subcutaneous tissue disorders | Eplerenone | 0 | 20 | |
| other | anxiety | Psychiatric disorders | Placebo | 1 | 22 | |
| other | anxiety | Psychiatric disorders | Eplerenone | 0 | 20 | |
| other | headache coincident with seasonal allergies | Nervous system disorders | Placebo | 0 | 22 | |
| other | headache coincident with seasonal allergies | Nervous system disorders | Eplerenone | 1 | 20 | |
| serious | death due to fat embolism | Vascular disorders | Placebo | 1 | 22 | |
| serious | death due to fat embolism | Vascular disorders | Eplerenone | 0 | 20 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Eplerenone | ||
| Total, other adverse events | Placebo | 2 | 22 |
| Total, other adverse events | Eplerenone | 1 | 20 |
| Total, serious adverse events | Placebo | 1 | 22 |
| Total, serious adverse events | Eplerenone | 0 | 20 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Eplerenone vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01521546
GET https://conductscience.org/api/trials/v1/NCT01521546/registered