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

Early Phase 1

Recruiting

• Conditions: Congenital Heart Disease; Thiamine Deficiency; Patent Ductus Arteriosus; Ventricular Septal Defect; Atrial Septal Defect
• Interventions: Drug: Thiamine

• Registration Number: NCT06298344
• Lead Sponsor: Universitas Sumatera Utara

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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-07
• Status Verified: 2024-05
• Study Start: 2024-05-01
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thiamine	Thiamine	Patients with left to right shunt congenital heart disease who undergone transcatheter closure Intervention: Daily Thiamine 100 mg in 28 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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, %)
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, %)

Trial Locations

Locations (1)

RSUP H Adam Malik; 🇮🇩 Medan, North Sumatera, Indonesia