Clinical trial NCT06298344: The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Congenital Heart Disease
Thiamine Deficiency
Patent Ductus Arteriosus
Ventricular Septal Defect
Atrial Septal Defect
Lead sponsor: Universitas Sumatera Utara
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 88
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between transcatheter closure and left ventricular structure change after thiamine treatment
timeFrame: 1 day before transcather closure and 28 days after trancatheter closure
Secondary outcomes:
measure: Correlation between transcatheter closure and left ventricular function change after thiamine treatment
timeFrame: 1 day before transcather closure and 28 days after trancatheter closure
measure: Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment
timeFrame: 1 day before transcather closure and 28 days after trancatheter closure
measure: Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment
timeFrame: 1 day before transcather closure and 28 days after trancatheter closure
Other outcomes:
Locations:
city: Medan
country: Indonesia
facility: RSUP H Adam Malik
state: North Sumatera
Study officials:
affiliation: Universitas Sumatera Utara
name: Putri Amelia
role: PRINCIPAL_INVESTIGATOR
References: