Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

University of Tehran38 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dilated Cardiomyopathy

Interventions

Coenzyme Q10DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Medical Center

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.