Congenital Heart DiseaseEarly Phase 1NCT06298344
The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease
A Early Phase 1 study testing Thiamine in people with Congenital Heart Disease and Thiamine Deficiency, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Congenital Heart Disease, Thiamine Deficiency, Patent Ductus Arteriosus
- What is being tested?
- Thiamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2024to 30 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients who experienced acute infections before the procedure.
- There are other heart defects that require surgery.
- There is a hereditary, genetic disorder, syndrome or other chronic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Specifically the investigators want to study about :
- 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.
- 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.
- 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.
- 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
- Congenital Heart Disease, Thiamine Deficiency, Patent Ductus Arteriosus, Ventricular Septal Defect, Atrial Septal Defect
- Being tested
- Thiamine
- Medical subject headings
- Heart Defects, Congenital, Thiamine Deficiency, Ductus Arteriosus, Patent, Heart Septal Defects, Ventricular, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamineDrug
Also called Vitamin B1
Daily Thiamine 100 mg in 28 days
| Study group | Role | What they receive |
|---|---|---|
| Thiamine | Experimental | Patients with left to right shunt congenital heart disease who undergone transcatheter closure Intervention: Daily Thiamine 100 mg in 28 days. Receives: Drug: Thiamine |
| Placebo | No intervention | Patients with left to right shunt congenital heart disease who undergone transcatheter closure Interventions: Daily Placebo oral (Manufactured to mimic Thiamine) in 28 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between transcatheter closure and left ventricular structure change after thiamine treatment
The left ventricular structure of each participant is measured with echocardiography at the beginning and the end of the study and then the investigators calculate the left ventricular structure change (in percentage, %)
Measured: 1 day before transcather closure and 28 days after trancatheter closure
Secondary outcomes (3)
Correlation between transcatheter closure and left ventricular function change after thiamine treatment
The left ventricular function of each participant is measured with echocardiography at the beginning and the end of the study and then the investigators calculate the left ventricular function change (in percentage, %)
Measured: 1 day before transcather closure and 28 days after trancatheter closure
Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment
The serum matrix metalloproteinase-9 level of each participant is measured at the beginning and the end of the study and then the investigators calculate the level change (in percentage, %)
Measured: 1 day before transcather closure and 28 days after trancatheter closure
Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment
The serum tissue inhibitor of metalloproteinase-1 level of each participant is measured at the beginning and the end of the study and then the investigators calculate the level change (in percentage, %)
Measured: 1 day before transcather closure and 28 days after trancatheter closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 May 2024
- Primary completion20 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Putri Amelia, Universitas Sumatera Utara
- Investigators
- Putri Amelia, Principal investigator, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298344
- Sponsor's protocol ID
- 002
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06298344
- Acronym / sponsor ID
- 002
- Conditions
- Congenital Heart Disease, Thiamine Deficiency, Patent Ductus Arteriosus, Ventricular Septal Defect, Atrial Septal Defect
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specifically the investigators want to study about :
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind
| Arm | Type | Receives |
|---|---|---|
| Thiamine | Experimental | Drug: ThiaminePatients with left to right shunt congenital heart disease who undergone transcatheter closure Intervention: Daily Thiamine 100 mg in 28 days. |
| Placebo | No intervention | –Patients with left to right shunt congenital heart disease who undergone transcatheter closure Interventions: Daily Placebo oral (Manufactured to mimic Thiamine) in 28 days. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who experienced acute infections before the procedure.
- There are other heart defects that require surgery.
- There is a hereditary, genetic disorder, syndrome or other chronic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiamineAlso: Vitamin B1Daily Thiamine 100 mg in 28 days | Drug | Thiamine |
Primary outcome
Correlation between transcatheter closure and left ventricular structure change after thiamine treatment
Time frame: 1 day before transcather closure and 28 days after trancatheter closure
The left ventricular structure of each participant is measured with echocardiography at the beginning and the end of the study and then the investigators calculate the left ventricular structure change (in percentage, %)
3 secondary outcomes
Correlation between transcatheter closure and left ventricular function change after thiamine treatment
Time frame: 1 day before transcather closure and 28 days after trancatheter closure
Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment
Time frame: 1 day before transcather closure and 28 days after trancatheter closure
Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment
Time frame: 1 day before transcather closure and 28 days after trancatheter closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Putri Amelia principal investigator
Universitas Sumatera Utara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Thiamine in people with Congenital Heart Disease and Thiamine Deficiency, run by Universitas Sumatera Utara at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between transcatheter closure and left ventricular structure change after thiamine treatment (time frame: 1 day before transcather closure and 28 days after trancatheter closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.