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

NCT06298344 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-03-24

No results posted yet for this study

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

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

Interventions

DRUG

Thiamine

Daily Thiamine 100 mg in 28 days

Sponsors & Collaborators

  • Universitas Sumatera Utara

    lead OTHER

Principal Investigators

  • Putri Amelia · Universitas Sumatera Utara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06298344 on ClinicalTrials.gov