Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

NCT ID: NCT02115581

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-03-31

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.

Conditions

Dilated Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Coenzyme Q10

Intervention Type: DRUG

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

known cases of idiopathic dilated cardiomyopathy who received placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Ubiquinone; no brand name

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tehran

OTHER

Sponsor Role: lead

Responsible Party

Giv Heidari-Bateni

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reza Shabanian, MD

Role: STUDY_DIRECTOR

Children's Medical Center

Armen Kocharian, MD

Role: STUDY_CHAIR

Children's Medical Center

Giv Heidari-Bateni, MD/MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Medical Center

Locations

Children's Medical Center

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

CoenzymeQ10 and Cardiomyopathy

Identifier Type: -

Identifier Source: org_study_id