An Early Phase 1 interventional study of Thiamine in Congenital Heart Disease, Thiamine Deficiency and Patent Ductus Arteriosus, sponsored by Universitas Sumatera Utara. Completed at 1 site in Indonesia. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Universitas Sumatera Utara · Early Phase 1, Interventional, and Treatment
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.
Specifically the investigators want to study about :
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's enrollment of 86 is above the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Universitas Sumatera Utara is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with left to right shunt congenital heart disease who undergone transcatheter closure Intervention: Daily Thiamine 100 mg in 28 days.
Drug: Thiamine
Patients with left to right shunt congenital heart disease who undergone transcatheter closure Interventions: Daily Placebo oral (Manufactured to mimic Thiamine) in 28 days.
Daily Thiamine 100 mg in 28 days
Also known as: Vitamin B1
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, %)
Time frame: 1 day before transcather closure and 28 days after trancatheter closure
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, %)
Time frame: 1 day before transcather closure and 28 days after trancatheter closure
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, %)
Time frame: 1 day before transcather closure and 28 days after trancatheter closure
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, %)
Time frame: 1 day before transcather closure and 28 days after trancatheter closure
Plan to share: No
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Ran from May 2024 to primary completion in Dec 2025, 19 months.
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thiamine
Universitas Sumatera Utara