Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

University of Tehran

Status and phase: Completed; Phase 4

Conditions: Dilated Cardiomyopathy

Treatments: Drug: Coenzyme Q10; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02115581

CoenzymeQ10 and Cardiomyopathy

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Coenzyme Q10

Experimental group

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.

Treatment:

Drug: Coenzyme Q10

Placebo

Placebo Comparator group

Description:

known cases of idiopathic dilated cardiomyopathy who received placebo

Treatment:

Drug: Placebo