Thiamine treatment after heart defect closure in children
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
This study is testing if giving thiamine to children with certain heart defects after surgery can help improve their heart function and structure.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | Universitas Sumatera Utara Academic / other |
| Locations | 1 site (Medan, North Sumatera) |
| Trial ID | NCT06298344 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of thiamine administration on children with left-to-right shunt congenital heart disease following transcatheter closure. Participants will receive 100 mg of thiamine daily for 28 days, and researchers will assess changes in serum levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1, as well as evaluate left ventricular structure and function through echocardiography. The goal is to determine if thiamine can improve heart function and structure in these patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 18 years diagnosed with left-to-right shunt lesions and heart failure.
Not a fit: Patients with acute infections, other heart defects requiring surgery, or chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance heart function and structural outcomes in children with congenital heart disease.
How similar studies have performed: This approach is novel and has not been previously tested in Indonesia, though similar studies may exist elsewhere.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Medan, North Sumatera
- RSUP H Adam Malik — Medan, North Sumatera, Indonesia (Recruiting)
Study contacts
- Principal investigator: Putri Amelia — Universitas Sumatera Utara
- Study coordinator: Putri Amelia
- Email: putri.amelia@usu.ac.id
- Phone: +6285261000273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.