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NCT Number: NCT06298344

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

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.

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Key information

Conditions

Congenital Heart Disease Atrial Septal Defect Avitaminosis Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Heart Septal Defects, Ventricular Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Patent Ductus Arteriosus Thiamine Deficiency Ventricular Septal Defect Vitamin B Deficiency

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

RSUP H Adam Malik

Medan, North Sumatera, 20136, Indonesia

About this study

Specifically the investigators want to study about :

  • 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.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 6 months - 18 years.
  • Patients diagnosed with left to right shunt lesion CHD with heart failure based on ROSS or NYHA criteria.
  • Patients who will undergo intervention with transcatheter closure.

Exclusion criteria

  • Patients who experienced acute infections before the procedure.
  • There are other heart defects that require surgery.
  • There is a hereditary, genetic disorder, syndrome or other chronic disease.

Treatment and study plan

Thiamine

Drug

Daily Thiamine 100 mg in 28 days

Other names: Vitamin B1

Primary outcomes

  1. Correlation between transcatheter closure and left ventricular structure change after thiamine treatment

    Time frame: 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 outcomes

  1. Correlation between transcatheter closure and left ventricular function change after thiamine treatment

    Time frame: 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, %)

  2. Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment

    Time frame: 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, %)

  3. Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment

    Time frame: 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, %)

Sponsors and collaborators

Lead sponsor

Universitas Sumatera Utara

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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