Clinical Trial: Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 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. 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.
Sponsor: University of Tehran

Current Primary Outcome:

  • Improvement in Left Ventricular Ejection Fraction [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse Events [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: University of Tehran

Dates:
Date Received: December 22, 2008
Date Started: September 2006
Date Completion:
Last Updated: March 14, 2014
Last Verified: March 2014