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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.
Specifically the investigators want to study about :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thiamine | Experimental | Patients with left to right shunt congenital heart disease who undergone transcatheter closure Intervention: Daily Thiamine 100 mg in 28 days. |
|
| Placebo | No Intervention | Patients with left to right shunt congenital heart disease who undergone transcatheter closure Interventions: Daily Placebo oral (Manufactured to mimic Thiamine) in 28 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiamine | Drug | Daily Thiamine 100 mg in 28 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Putri Amelia | Universitas Sumatera Utara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUP H Adam Malik | Medan | North Sumatera | 20136 | Indonesia |
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Double blind
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D013832 | Thiamine Deficiency |
| D004374 | Ductus Arteriosus, Patent |
| D006345 | Heart Septal Defects, Ventricular |
| D006344 | Heart Septal Defects, Atrial |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006343 | Heart Septal Defects |
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| ID | Term |
|---|---|
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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