Back to resultsCoenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy
Primary Purpose
Dilated Cardiomyopathy
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Coenzyme Q10
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring Coenzyme O10, Children, Idiopathic Dilated Cardiomyopathy
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
Sites / Locations
- Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Coenzyme Q10
Placebo
Arm 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.
known cases of idiopathic dilated cardiomyopathy who received placebo
Outcomes
Primary Outcome Measures
Improvement in Left Ventricular Ejection Fraction
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02115581
Brief Title
Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy
Official Title
Effect of Coenzyme Q10 (Ubiquinone) Supplementation on Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy.A Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tehran
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy
Keywords
Coenzyme O10, Children, Idiopathic Dilated Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coenzyme Q10
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
known cases of idiopathic dilated cardiomyopathy who received placebo
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10
Other Intervention Name(s)
Ubiquinone
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
no brand name
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement in Left Ventricular Ejection Fraction
Description
Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography
Time Frame
6 months
Title
Improvement in Left Ventricular Filling Abnormality
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adverse Events
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Shabanian, MD
Organizational Affiliation
Children's Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Armen Kocharian, MD
Organizational Affiliation
Children's Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giv Heidari-Bateni, MD/MPH
Organizational Affiliation
Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Medical Center
City
Tehran
ZIP/Postal Code
14194
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy
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