Atrial Septal Defect, Congenital Heart Disease, Patent Ductus Arteriosus, Thiamine Deficiency, Ventricular Septal Defect
Conditions
Brief summary
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.
Detailed description
Specifically the investigators want to study about : 1. 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. 2. 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. 3. 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. 4. 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.
Interventions
DRUGThiamine
Daily Thiamine 100 mg in 28 days
Sponsors
Universitas Sumatera Utara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Double blind
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 6 months - 18 years. 2. Patients diagnosed with left to right shunt lesion CHD with heart failure based on ROSS or NYHA criteria. 3. Patients who will undergo intervention with transcatheter closure.
Exclusion criteria
1. Patients who experienced acute infections before the procedure. 2. There are other heart defects that require surgery. 3. There is a hereditary, genetic disorder, syndrome or other chronic disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between transcatheter closure and left ventricular structure change after thiamine treatment | 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, %) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between transcatheter closure and left ventricular function change after thiamine treatment | 1 day before transcather closure and 28 days after trancatheter closure | The left ventricular function of each participant is measured with echocardiography at the beginning and the end of the study and then the investigators calculate the left ventricular function change (in percentage, %) |
| 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 | The serum matrix metalloproteinase-9 level of each participant is measured at the beginning and the end of the study and then the investigators calculate the level change (in percentage, %) |
| 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 | The serum tissue inhibitor of metalloproteinase-1 level of each participant is measured at the beginning and the end of the study and then the investigators calculate the level change (in percentage, %) |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORPutri Amelia
Universitas Sumatera Utara
Outcome results
None listed