Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

Phase 4

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	known cases of idiopathic dilated cardiomyopathy who received placebo
Coenzyme Q10	Coenzyme Q10	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.

Primary Outcome Measures

Name	Time	Method
Improvement in Left Ventricular Ejection Fraction	6 months	Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography
Improvement in Left Ventricular Filling Abnormality	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	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.