Trial Outcomes & Findings for Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy (NCT NCT02115581)

Results Overview

Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

38 participants

Primary outcome timeframe

6 months

Results posted on

2014-04-16

Participant Flow

Patients younger than 18 years with known diagnosis of primary dilated cardiomyopathy referred for follow-up echocardiography to Children's Medical Center between September 2006 to March 2008 were recruited.

Participant milestones

Participant milestones
Measure	Coenzyme Q10 Known cases of idiopathic dilated cardiomyopathy who received Co Q10	Placebo Known cases of idiopathic dilated cardiomyopathy who received the placebo
Overall Study STARTED	17	21
Overall Study COMPLETED	17	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conezyme Q10 n=17 Participants known cases of idiopathic dilated cardiomyopathy who received Co Q10	Placebo n=21 Participants known cases of idiopathic dilated cardiomyopathy who received the placebo	Total n=38 Participants Total of all reporting groups
Age, Continuous	6.3 years STANDARD_DEVIATION 4.5 • n=5 Participants	7.3 years STANDARD_DEVIATION 5.2 • n=7 Participants	6.9 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	17 participants n=5 Participants	21 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography

Outcome measures

Outcome measures
Measure	Conezyme Q10 n=17 Participants Known cases of idiopathic dilated cardiomyopathy who received Co Q10	Placebo n=21 Participants Known cases of idiopathic dilated cardiomyopathy who received the placebo
Improvement in Left Ventricular Ejection Fraction	42.1 Percentage Standard Deviation 14.7	37.6 Percentage Standard Deviation 9.7

PRIMARY outcome

Timeframe: 6 months

Doppler-derived transmitral blood flow and pulmonary venous blood flow data were used for grading of the severity of diastolic filling abnormality in patients before and after the intervention. Diastolic filling abnormality was categorized as: 1- normal 2- abnormal relaxation 3- pseudonormal 4- restricted pattern based on echo data. The proportion of patients who showed improvement in the diastolic function grading was compared between the study groups.

Outcome measures

Outcome measures
Measure	Conezyme Q10 n=17 Participants Known cases of idiopathic dilated cardiomyopathy who received Co Q10	Placebo n=21 Participants Known cases of idiopathic dilated cardiomyopathy who received the placebo
Improvement in Left Ventricular Filling Abnormality	59 Percentage	19 Percentage

SECONDARY outcome

Timeframe: 6 months

Number of patients with evidence of adverse reaction to coenzyme Q10 including nausea, vomiting, changes in blood pressure, neurological signs or any abnormal behavior like disquiet in young children.

Outcome measures

Outcome measures
Measure	Conezyme Q10 n=17 Participants Known cases of idiopathic dilated cardiomyopathy who received Co Q10	Placebo n=21 Participants Known cases of idiopathic dilated cardiomyopathy who received the placebo
Adverse Events	0 Participants	0 Participants

Adverse Events

Coenzyme Q10 (Study Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (Control Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Giv Heidari-Bateni MD/MPH

Children's Medical Center

Phone: 3142991984

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place