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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298344
• Other study ID #: 002
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: Universitas Sumatera Utara
• Contact: Putri Amelia
• Phone: +6285261000273
• Email: putri.amelia[@]usu.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Atrial Septal Defect
• Beriberi
• Congenital Heart Disease
• Ductus Arteriosus, Patent
• Heart Defects, Congenital
• Heart Diseases
• Heart Septal Defects
• Heart Septal Defects, Atrial
• Heart Septal Defects, Ventricular
• Patent Ductus Arteriosus
• Thiamine Deficiency
• Ventricular Septal Defect

Intervention

Drug:
• Thiamine
Daily Thiamine 100 mg in 28 days

Locations

Country	Name	City	State
Indonesia	RSUP H Adam Malik	Medan	North Sumatera

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sumatera Utara

Country where clinical trial is conducted

Indonesia, 

Outcome

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