Trial Outcomes & Findings for Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy (NCT NCT01521546)

Results Overview

a sensitive measurement of heart function using cardiac MRI, change was 12 months minus baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

baseline and 12 months

Results posted on

2016-11-08

Enrollment was required prior to assignment.

Participant milestones
Measure	Placebo placebo placebo: one tablet by mouth daily for 12 months	Eplerenone active study drug eplerenone: 25mg tablet, once daily by mouth for 12 months
Overall Study STARTED	22	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	2	0

Withdrawal data not reported

Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy

Baseline characteristics by cohort
Measure	Eplerenone n=20 Participants active study drug eplerenone: 25mg tablet, once daily by mouth for 12 months	Placebo n=22 Participants placebo placebo: one tablet by mouth daily for 12 months	Total n=42 Participants Total of all reporting groups
Age, Continuous Age	14.5 years n=5 Participants	15.0 years n=7 Participants	15.0 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants

Timeframe: baseline and 12 months

a sensitive measurement of heart function using cardiac MRI, change was 12 months minus baseline.

Outcome measures
Measure	Placebo n=20 Participants placebo: one tablet by mouth daily for 12 months	Eplerenone n=20 Participants eplerenone one tablet by mouth daily for 12 months
12-month Change in Myocardial Strain	2.2 percent change in heart dimension Interval 1.3 to 3.1	1.0 percent change in heart dimension Interval 0.3 to 2.2

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events
Measure	Placebo n=22 participants at risk placebo one tablet daily for 12 months	Eplerenone n=20 participants at risk eplerenone one tablet daily for 12 months
Vascular disorders death due to fat embolism	4.5% 1/22	0.00% 0/20

Other adverse events
Measure	Placebo n=22 participants at risk placebo one tablet daily for 12 months	Eplerenone n=20 participants at risk eplerenone one tablet daily for 12 months
Skin and subcutaneous tissue disorders flushing	4.5% 1/22	0.00% 0/20
Psychiatric disorders anxiety	4.5% 1/22	0.00% 0/20
Nervous system disorders headache coincident with seasonal allergies	0.00% 0/22	5.0% 1/20

The Ohio State University

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