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

NCT06298344 | Completed Early Phase 1

• 1 other identifier: 002
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thiamine Deficiency; Patent Ductus Arteriosus; Atrial Septal Defect; Congenital Heart Disease; Ventricular Septal Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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

  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

  1 day before transcather closure and 28 days after trancatheter closure

Study Arms (2)

Thiamine

EXPERIMENTAL

Patients with left to right shunt congenital heart disease who undergone transcatheter closure Intervention: Daily Thiamine 100 mg in 28 days.

Drug: Thiamine

Placebo

NO INTERVENTION

Patients with left to right shunt congenital heart disease who undergone transcatheter closure Interventions: Daily Placebo oral (Manufactured to mimic Thiamine) in 28 days.

Interventions

Thiamine DRUG

Daily Thiamine 100 mg in 28 days

Also known as: Vitamin B1

Thiamine

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

RSUP H Adam Malik

Medan, North Sumatera, 20136, Indonesia

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Thiamine Deficiency; Ductus Arteriosus, Patent; Heart Septal Defects, Ventricular; Heart Septal Defects, Atrial

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Heart Septal Defects

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Putri Amelia

  Universitas Sumatera Utara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Putri Amelia, M.Ked (Ped), Sp.A(K)

Model Details: Double blind

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 7, 2024
• Study Start: May 1, 2024
• Primary Completion: December 20, 2025
• Study Completion: December 30, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)