Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

Dilated Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115581
• Other study ID #: CoenzymeQ10 and Cardiomyopathy
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2008
• Last updated: March 14, 2014
• Start date: September 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2014
• Source: University of Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Drug:
• Coenzyme Q10
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
• Placebo
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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Children's Medical Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	Yes