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Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02115581
First Posted: April 16, 2014
Last Update Posted: April 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Giv Heidari-Bateni, University of Tehran
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Giv Heidari-Bateni, University of Tehran:

Primary Outcome Measures:
  • 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

  • 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 Outcome Measures:
  • 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.


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

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Giv Heidari-Bateni, Research Fellow, University of Tehran
ClinicalTrials.gov Identifier: NCT02115581     History of Changes
Other Study ID Numbers: CoenzymeQ10 and Cardiomyopathy
First Submitted: December 22, 2008
First Posted: April 16, 2014
Results First Submitted: December 22, 2008
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014
Last Verified: March 2014

Keywords provided by Giv Heidari-Bateni, 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
Vitamins