Trial Outcomes & Findings for Cardiomyopathy in DMD: Lisinopril vs. Losartan (NCT NCT01982695)

Results Overview

Mean cardiac ejection fraction as measured by echocardiogram at 12 month study visit. Cardiac ejection fractions were measured using the biplane Simpson's rule using images obtained from the apical 4 chamber views of the heart.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

12 month visit

Results posted on

2017-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Lisinopril Approximately 0.07 mg/kg/day in oral capsules	Losartan Approximately 0.7 mg/kg/day in oral capsules
Overall Study STARTED	12	11
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cardiomyopathy in DMD: Lisinopril vs. Losartan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lisinopril n=12 Participants Lisinopril	Lospartan n=11 Participants Lisinopril	Total n=23 Participants Total of all reporting groups
Age, Continuous	12.5 years n=5 Participants	15.5 years n=7 Participants	14 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	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ejection Fraction	47.5 percentage of blood leaving the heart STANDARD_DEVIATION 6.25 • n=5 Participants	47.7 percentage of blood leaving the heart STANDARD_DEVIATION 5.49 • n=7 Participants	47.6 percentage of blood leaving the heart STANDARD_DEVIATION 5.77 • n=5 Participants

PRIMARY outcome

Timeframe: 12 month visit

Population: All patients that received a 12 month echocardiogram evaluation

Mean cardiac ejection fraction as measured by echocardiogram at 12 month study visit. Cardiac ejection fractions were measured using the biplane Simpson's rule using images obtained from the apical 4 chamber views of the heart.

Outcome measures

Outcome measures
Measure	Lisinopril n=7 Participants Lisinopril	Losartan n=9 Participants Losartan
Cardiac Ejection Fraction as Measured by Echocardiogram	54.6 percentage of blood leaving the heart Standard Deviation 5.19	55.2 percentage of blood leaving the heart Standard Deviation 7.19

Adverse Events

Lisinopril

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Losartan

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lisinopril n=12 participants at risk Lisinopril	Losartan n=10 participants at risk Losartan
Skin and subcutaneous tissue disorders Allergic reaction to medication	0.00% 0/12	10.0% 1/10 • Number of events 1
Cardiac disorders Cardiomyopathy	0.00% 0/12	10.0% 1/10 • Number of events 1

Additional Information

Dr. Jerry R. Mendell

Nationwide Children's Hopsital

Phone: (614) 722-5615

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place