The Role of Thiamine on Left Ventricular Structure and Function After Transcatheter Closure Through the Examination of MMP-9 Dan TIMP-1 in Children With Left-to-Right Shunt Congenital Heart Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Correlation between transcatheter closure and left ventricular structure change after thiamine treatment
研究概览
简要总结
Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions.
详细描述
Specifically the investigators want to study about :
- The differences in serum levels of matrix metalloproteinase-9 in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who received thiamine and those who did not receive thiamine.
- The differences in serum tissue inhibitor of metalloproteinase-1 levels in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who received thiamine and those who did not receive thiamine.
- The differences in left ventricular structure in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who receive thiamine and those who do not receive thiamine.
- The differences in left ventricular function in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who receive thiamine and those who do not receive thiamine.
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, Investigator)
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
- •Patients aged 6 months - 18 years.
- •Patients diagnosed with left to right shunt lesion CHD with heart failure based on ROSS or NYHA criteria.
- •Patients who will undergo intervention with transcatheter closure.
排除标准
- •Patients who experienced acute infections before the procedure.
- •There are other heart defects that require surgery.
- •There is a hereditary, genetic disorder, syndrome or other chronic disease.
研究组 & 干预措施
Thiamine
Patients with left to right shunt congenital heart disease who undergone transcatheter closure Intervention: Daily Thiamine 100 mg in 28 days.
干预措施: Thiamine (Drug)
结局指标
主要结局
Correlation between transcatheter closure and left ventricular structure change after thiamine treatment
时间窗: 1 day before transcather closure and 28 days after trancatheter closure
The left ventricular structure of each participant is measured with echocardiography at the beginning and the end of the study and then the investigators calculate the left ventricular structure change (in percentage, %)
次要结局
- Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment(1 day before transcather closure and 28 days after trancatheter closure)
- Correlation between transcatheter closure and left ventricular function change after thiamine treatment(1 day before transcather closure and 28 days after trancatheter closure)
- Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment(1 day before transcather closure and 28 days after trancatheter closure)
研究者
Putri Amelia
dr. Putri Amelia, M.Ked (Ped), Sp.A(K)
Universitas Sumatera Utara