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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Indonesia
RSUP H Adam Malik
RECRUITING
Medan
Contact Information
Primary
Putri Amelia
putri.amelia@usu.ac.id
+6285261000273
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 88
Treatments
Experimental: Thiamine
Patients with left to right shunt congenital heart disease who undergone transcatheter closure Intervention: Daily Thiamine 100 mg in 28 days.
No_intervention: Placebo
Patients with left to right shunt congenital heart disease who undergone transcatheter closure Interventions: Daily Placebo oral (Manufactured to mimic Thiamine) in 28 days.
Sponsors
Leads: Universitas Sumatera Utara

This content was sourced from clinicaltrials.gov