Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giv Heidari-Bateni, University of Tehran
ClinicalTrials.gov Identifier:
NCT02115581
First received: December 22, 2008
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Dilated Cardiomyopathy
Drug: Coenzyme Q10
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Coenzyme Q10 (Ubiquinone) Supplementation on Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy.A Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Tehran:

Primary Outcome Measures:
  • Improvement in Left Ventricular Ejection Fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography

  • Improvement in Left Ventricular Filling Abnormality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 38
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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
Other Name: Ubiquinone
Placebo Comparator: Placebo
known cases of idiopathic dilated cardiomyopathy who received placebo
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
Other Name: no brand name

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02115581

Locations
Iran, Islamic Republic of
Children's Medical Center
Tehran, Iran, Islamic Republic of, 14194
Sponsors and Collaborators
University of Tehran
Investigators
Study Director: Reza Shabanian, MD Children's Medical Center
Study Chair: Armen Kocharian, MD Children's Medical Center
Principal Investigator: Giv Heidari-Bateni, MD/MPH Children's Medical Center
  More Information

No publications provided

Responsible Party: Giv Heidari-Bateni, Research Fellow, University of Tehran
ClinicalTrials.gov Identifier: NCT02115581     History of Changes
Other Study ID Numbers: CoenzymeQ10 and Cardiomyopathy
Study First Received: December 22, 2008
Results First Received: December 22, 2008
Last Updated: March 14, 2014
Health Authority: Iran: Ethics Committee

Keywords provided by University of Tehran:
Coenzyme O10
Children
Idiopathic Dilated Cardiomyopathy

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on October 19, 2014