Dilated Cardiomyopathy
Conditions
Keywords
Coenzyme O10, Children, Idiopathic Dilated Cardiomyopathy
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.
Interventions
DRUGCoenzyme 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
DRUGPlacebo
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
Sponsors
University of Tehran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Left Ventricular Ejection Fraction | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 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. |
Countries
Iran
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Conezyme Q10 known cases of idiopathic dilated cardiomyopathy who received Co Q10 | 17 |
| Placebo known cases of idiopathic dilated cardiomyopathy who received the placebo | 21 |
| Total | 38 |
Baseline characteristics
| Characteristic | Conezyme Q10 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 6.3 years STANDARD_DEVIATION 4.5 | 7.3 years STANDARD_DEVIATION 5.2 | 6.9 years STANDARD_DEVIATION 5.5 |
| Region of Enrollment Iran, Islamic Republic of | 17 participants | 21 participants | 38 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 21 |
| serious Total, serious adverse events | 0 / 17 | 0 / 21 |
Outcome results
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conezyme Q10 | Improvement in Left Ventricular Ejection Fraction | 42.1 Percentage | Standard Deviation 14.7 |
| Placebo | Improvement in Left Ventricular Ejection Fraction | 37.6 Percentage | Standard Deviation 9.7 |
p-value: 0.267Wilcoxon (Mann-Whitney)
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conezyme Q10 | Improvement in Left Ventricular Filling Abnormality | 59 Percentage |
| Placebo | Improvement in Left Ventricular Filling Abnormality | 19 Percentage |
p-value: 0.011Fisher Exact
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conezyme Q10 | Adverse Events | 0 Participants |
| Placebo | Adverse Events | 0 Participants |