The Role of Thiamine After Transcatheter Closure in Children With

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06298344
Study type	Interventional
Source	Universitas Sumatera Utara
Contact	Putri Amelia
Phone	+6285261000273
Email	putri.amelia@usu.ac.id
Status	Recruiting
Phase	Early Phase 1
Start date	May 1, 2024
Completion date	January 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms