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

Launched by UNIVERSITAS SUMATERA UTARA · Feb 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of thiamine, a vitamin, on children with certain types of congenital heart disease (CHD) who have a condition called left-to-right shunt. This occurs when blood flows improperly through the heart, causing heart failure. The study involves giving participants 100 mg of thiamine daily for 28 days after a procedure called transcatheter closure, which is used to fix the heart's blood flow. Researchers will monitor changes in heart function and structure by measuring specific proteins in the blood and using echocardiography, a test that uses sound waves to create images of the heart.

To be eligible for this trial, children between the ages of 6 months and 18 years who have been diagnosed with a left-to-right shunt and are experiencing heart failure may participate. However, children with other serious heart defects, acute infections, or certain genetic disorders will not be included. Participants can expect regular monitoring during the study, and the goal is to understand if thiamine can help improve heart function in these patients. This research is important because it is the first of its kind in Indonesia, aiming to provide better care for children with congenital heart disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 6 months - 18 years.
• • 2. Patients diagnosed with left to right shunt lesion CHD with heart failure based on ROSS or NYHA criteria.
• • 3. Patients who will undergo intervention with transcatheter closure.
• Exclusion Criteria:
• • 1. Patients who experienced acute infections before the procedure.
• • 2. There are other heart defects that require surgery.
• • 3. There is a hereditary, genetic disorder, syndrome or other chronic disease.