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This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to 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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coenzyme Q10 | Experimental | 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. |
|
| Placebo | Placebo Comparator | known cases of idiopathic dilated cardiomyopathy who received placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Shabanian, MD | Children's Medical Center | Study Director |
| Armen Kocharian, MD | Children's Medical Center | Study Chair |
| Giv Heidari-Bateni, MD/MPH | Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Medical Center | Tehran | Tehran Province | 14194 | Iran |
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Patients younger than 18 years with known diagnosis of primary dilated cardiomyopathy referred for follow-up echocardiography to Children's Medical Center between September 2006 to March 2008 were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coenzyme Q10 | Known cases of idiopathic dilated cardiomyopathy who received Co Q10 |
| FG001 | Placebo | Known cases of idiopathic dilated cardiomyopathy who received the placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conezyme Q10 | known cases of idiopathic dilated cardiomyopathy who received Co Q10 |
| BG001 | Placebo | known cases of idiopathic dilated cardiomyopathy who received the placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Posted | Number | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coenzyme Q10 (Study Group) | Known cases of idiopathic dilated cardiomyopathy 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giv Heidari-Bateni MD/MPH | Children's Medical Center | 3142991984 | givhb@yahoo.com |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
| D014451 | Ubiquinone |
| ID | Term |
|---|---|
| D016227 | Benzoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D003067 | Coenzymes |
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| 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 |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | Percentage | 6 months |
|
|
|
|
| Primary | 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. | Posted | Number | Percentage | 6 months |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Placebo (Control Group) | Known cases of idiopathic dilated cardiomyopathy 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 | 0 | 21 | 0 | 21 |
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| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D045762 |
| Enzymes and Coenzymes |