Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

Study Overview
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Brief Summary
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This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy.

Detailed Description
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This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy. In a prospective, randomized, double-blinded, placebo-controlled trial, patients younger than 18 years with idiopathic dilated cardiomyopathy randomizes to receive either Coenzyme Q10 or placebo. Echocardiographic systolic and diastolic function parameters are determined for every patient at baseline, after three,six and nine months of supplementation.

Official Title
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Effect of Coenzyme Q10 (Ubiquinone) Supplementation on Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy.A Randomised Clinical Trial

Conditions
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Dilated Cardiomyopathy

Intervention / Treatment
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* Drug: Coenzyme Q10
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known cases of Idiopathic Dilated Cardiomyopathy (IDC) Those patients in whom heart failure medications were stable for at least 1 month More than 6 months aged Exclusion Criteria: Recent modification in medications Hemodynamic instability Congenital heart disease Metabolic heart disease Cardiac dysfunction resulting from abnormalities in other organs and those with an acquired cardiomyopathy

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coenzyme Q10<br>Known cases of idiopathic dilated cardiomyopathy who received supplementation of coenzyme Q10 as a part of their medical regimen. Dosage administered: 2 milligram/kilogram/day in 2 or 3 divided doses, these being increased to the maximum dose of 10 milligram/kilogram/day according to tolerance or the appearance of sideeffects. | Drug: Coenzyme Q10<br>* dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance<br>* Other names: Ubiquinone;|
| Placebo Comparator: Placebo<br>known cases of idiopathic dilated cardiomyopathy who received placebo | Drug: Placebo<br>* dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance<br>* Other names: no brand name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Left Ventricular Ejection Fraction | Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography | 6 months | 
| Improvement in Left Ventricular Filling Abnormality | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coenzyme O10, Children, Idiopathic Dilated Cardiomyopathy