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Completed

NCT Number: NCT02115581

Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

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

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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Laminopathies

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Medical Center

Tehran, Tehran Province, 14194, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coenzyme Q10

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

Other names: Ubiquinone

Placebo

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

Other names: no brand name

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Tehran

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 16, 2014
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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