Brief Title
Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy
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 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Improvement in Left Ventricular Ejection Fraction
Secondary Outcome
Adverse Events
Condition
Dilated Cardiomyopathy
Intervention
Coenzyme Q10
Study Arms / Comparison Groups
Coenzyme Q10
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
38
Start Date
September 2006
Completion Date
March 2008
Primary Completion Date
March 2008
Eligibility Criteria
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
Gender
All
Ages
6 Months - 18 Years
Accepts Healthy Volunteers
No
Contacts
Reza Shabanian, MD, ,
Location Countries
Iran, Islamic Republic of
Location Countries
Iran, Islamic Republic of
Administrative Informations
NCT ID
NCT02115581
Organization ID
CoenzymeQ10 and Cardiomyopathy
Responsible Party
Principal Investigator
Study Sponsor
University of Tehran
Study Sponsor
Reza Shabanian, MD, Study Director, Children's Medical Center
Verification Date
March 2014