Effect of Coenzyme Q10 (Ubiquinone) Supplementation on Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy.A Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Improvement in Left Ventricular Ejection Fraction
研究概览
简要总结
This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Coenzyme Q10 (Drug)
Placebo
known cases of idiopathic dilated cardiomyopathy who received placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in Left Ventricular Ejection Fraction
时间窗: 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
时间窗: 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.
次要结局
- Adverse Events(6 months)
研究者
Giv Heidari-Bateni
Research Fellow
University of Tehran