drugset / Trial / NCT06298344

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

NCT06298344

Phase 0 Completed 86 enrolled Universitas Sumatera Utara
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-05-01
Primary completion
2025-12-20
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Thiamine Other / unclassified 100 mg