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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-01-01

Brief Summary

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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.

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Drug Effect

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Detailed Description

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Specifically the investigators want to study about :

1. The differences in serum levels of matrix metalloproteinase-9 in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who received thiamine and those who did not receive thiamine.
2. The differences in serum tissue inhibitor of metalloproteinase-1 levels in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who received thiamine and those who did not receive thiamine.
3. The differences in left ventricular structure in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who receive thiamine and those who do not receive thiamine.
4. The differences in left ventricular function in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who receive thiamine and those who do not receive thiamine.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Thiamine

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

Group Type EXPERIMENTAL

Thiamine

Intervention Type DRUG

Daily Thiamine 100 mg in 28 days

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Thiamine

Daily Thiamine 100 mg in 28 days

Intervention Type DRUG

Other Intervention Names

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Vitamin B1

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No