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The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease

Recruiting
6 - 18 years of age
Both
Phase N/A

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Overview

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.

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.

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.

Study details

Congenital Heart Disease, Thiamine Deficiency, Patent Ductus Arteriosus, Ventricular Septal Defect, Atrial Septal Defect

NCT06298344

Universitas Sumatera Utara

15 May 2024

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