Congenital Heart Disease Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 88 |
Est. completion date | January 1, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | RSUP H Adam Malik | Medan | North Sumatera |
Lead Sponsor | Collaborator |
---|---|
Universitas Sumatera Utara |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between transcatheter closure and left ventricular structure change after thiamine treatment | 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, %) | 1 day before transcather closure and 28 days after trancatheter closure | |
Secondary | Correlation between transcatheter closure and left ventricular function change after thiamine treatment | 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, %) | 1 day before transcather closure and 28 days after trancatheter closure | |
Secondary | Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment | 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, %) | 1 day before transcather closure and 28 days after trancatheter closure | |
Secondary | Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment | 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, %) | 1 day before transcather closure and 28 days after trancatheter closure |
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