Tetralogy of Fallot (TOF)Early Phase 1NCT07194304
Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot
A Early Phase 1 study testing alpha-Tocopherol and Sterile Water for Injection in people with Tetralogy of Fallot (TOF) and Alpha-tocopherol, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial summary
Introduction: Tetralogy of Fallot (ToF) correction with cardiopulmonary bypass (CPB) poses a risk of ischemia-reperfusion injury, especially in cyanotic myocardium. Alpha-tocopherol, a potent antioxidant, may reduce myocardial damage during surgery. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Tetralogy of Fallot (TOF), Alpha-tocopherol, Cardiac Surgery
- What is being tested?
- alpha-Tocopherol and Sterile Water for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2022to 1 Jun 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of congenital heart disease Tetralogy of Fallot (ToF)
- Age between 1 and 10 years
- Scheduled for definitive repair of ToF using cardiopulmonary bypass (CPB) at PJT-RSCM
Who cannot join
- History of prior palliative surgery (e.g., Blalock-Taussig shunt)
- Presence of additional congenital heart disease requiring major modification or addition of surgical procedures
- History of central nervous system disorder or stroke
- History of cardiopulmonary resuscitation (CPR)
- Undergoing redo surgery (e.g., residual stenosis, bleeding)
Trial locations and contacts
1 site in 1 country.
About this study
Introduction:
Tetralogy of Fallot (ToF) correction with cardiopulmonary bypass (CPB) poses a risk of ischemia-reperfusion injury, especially in cyanotic myocardium. Alpha-tocopherol, a potent antioxidant, may reduce myocardial damage during surgery.
Methods:
This randomized controlled trial included 58 ToF patients aged 1-10 years undergoing definitive surgery with CPB at Integrated Heart Center, Cipto Mangunkusumo Hospital. Patients were randomly assigned to receive either parenteral alpha-tocopherol (4 mg/kg) or placebo at the initiation of CPB. The primary outcome was postoperative troponin I level.
- Conditions
- Tetralogy of Fallot (TOF), Alpha-tocopherol, Cardiac Surgery
- Being tested
- alpha-Tocopherol, Sterile Water for Injection
- Keywords
- TOF, alpha-tocopherol, cardiac surgery, troponin I
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha-TocopherolDrug
patients in the intervention group received parenteral alpha-tocopherol at a dose of 4 mg/kg body weight
Sterile Water for InjectionDrug
the control group received a placebo (sterile water for injection/aquabidest)
| Study group | Role | What they receive |
|---|---|---|
| alpha-tocopherol | Experimental | assigned to receive either parenteral alpha-tocopherol (4 mg/kg) Receives: Drug: alpha-Tocopherol |
| sterile water for injection | Placebo comparator | the control group received a placebo (sterile water for injection/aquabidest) Receives: Drug: Sterile Water for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Troponin I Concentration (ng/L)
Serum Troponin I concentration will be measured at baseline (before surgery), 1 hour after surgery, and 8 hours after surgery to assess the extent of myocardial injury associated with cardiopulmonary bypass during Tetralogy of Fallot repair.
Measured: Before surgery, 1 hour after surgery, and 8 hours after surgery
Secondary outcomes (10)
Change in Serum Malondialdehyde (MDA) Concentration (ng/mL)
Serum malondialdehyde (MDA), a biomarker of oxidative stress, will be measured at baseline (before surgery), 1 hour after surgery, and 8 hours after surgery to evaluate oxidative injury associated with cardiopulmonary bypass during Tetralogy of Fallot repair.
Measured: Before surgery, 1 hour after surgery, and 8 hours after surgery
Change in Serum Lactate Concentration (mmol/L)
Serum lactate levels will be measured at baseline (before surgery), and at 1 hour, 6 hours, 12 hours, and 24 hours after surgery to evaluate tissue perfusion and metabolic response associated with cardiopulmonary bypass during Tetralogy of Fallot repair.
Measured: Before surgery, 1 hour, 6 hours, 12 hours, and 24 hours after surgery
Myocardial Injury Score (Histopathology, Scale 0-3)
Myocardial tissue injury will be assessed from biopsy samples collected 15 minutes after release of the aortic cross-clamp. Injury will be graded on a histopathological scale ranging from 0 to 3, where 0 = no injury and 3 = severe injury. Higher scores indicate worse myocardial damage.
Measured: 15 minutes after release of the aortic cross-clamp
Apoptotic Index (% of Apoptotic Cardiomyocytes)
The apoptotic index will be calculated from myocardial tissue samples collected 15 minutes after release of the aortic cross-clamp. Sections are stained with TUNEL and examined at 40× magnification across 6 hotspot areas. The index is expressed as the percentage of TUNEL-positive cardiomyocytes per 100 cardiomyocytes. The scale ranges from 0% (no apoptosis) to 100% (all cells apoptotic). Higher values indicate greater myocardial apoptosis.
Measured: tissue sample is collected 15 minutes after releasing the aortic cross clamp
Duration of Mechanical Ventilation (hours)
Duration of postoperative mechanical ventilation will be recorded in hours.
Measured: From end of surgery until extubation
anti-cTnI
Measured: tissue sample is collected 15 minutes after releasing the aortic cross clamp
GPx expression
Measured: tissue sample is collected 15 minutes after releasing the aortic cross clamp
Intensive Care Unit Length of Stay (days)
ICU length of stay will be recorded in days from ICU admission until ICU discharge.
Measured: From ICU admission until ICU discharge, assessed up to 14 days
Hospital Length of Stay (days)
Hospital length of stay will be recorded in days from hospital admission until discharge.
Measured: From hospital admission until hospital discharge, assessed up to 30 days
Vasoactive-Inotropic Score (VIS, Scale 0-X)
Vasoactive-Inotropic Score (VIS) will be calculated to quantify the amount of vasoactive support required after surgery. The VIS scale ranges from 0 to an open-ended maximum value; higher scores indicate greater need for vasoactive support and worse hemodynamic status.
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 May 2022
- Primary completion1 Jan 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of Fallot (TOF)Studies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suprayitno Wardoyo, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194304
- Sponsor's protocol ID
- KET-273/UN2.F1/ETIK/PPM.00.02/
- Status last verified
- Sep 2025
- First submitted
- 4 Jul 2025
- Last updated
- 26 Sep 2025
- Results posted
- 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 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT07194304
- Acronym / sponsor ID
- KET-273/UN2.F1/ETIK/PPM.00.02/
- Conditions
- Tetralogy of Fallot (TOF), Alpha-tocopherol, Cardiac Surgery
- Keywords
- TOF, alpha-tocopherol, cardiac surgery, troponin I
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 26 Sep 2025 (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.
Introduction:
Tetralogy of Fallot (ToF) correction with cardiopulmonary bypass (CPB) poses a risk of ischemia-reperfusion injury, especially in cyanotic myocardium. Alpha-tocopherol, a potent antioxidant, may reduce myocardial damage during surgery.
Methods:
This randomized controlled trial included 58 ToF patients aged 1-10 years undergoing definitive surgery with CPB at Integrated Heart Center, Cipto Mangunkusumo Hospital. Patients were randomly assigned to receive either parenteral alpha-tocopherol (4 mg/kg) or placebo at the initiation of CPB. The primary outcome was postoperative troponin I level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alpha-tocopherol | Experimental | Drug: alpha-Tocopherolassigned to receive either parenteral alpha-tocopherol (4 mg/kg) |
| sterile water for injection | Placebo comparator | Drug: Sterile Water for Injectionthe control group received a placebo (sterile water for injection/aquabidest) |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of congenital heart disease Tetralogy of Fallot (ToF)
- Age between 1 and 10 years
- Scheduled for definitive repair of ToF using cardiopulmonary bypass (CPB) at PJT-RSCM
Key exclusion criteria (5 listed)
- History of prior palliative surgery (e.g., Blalock-Taussig shunt)
- Presence of additional congenital heart disease requiring major modification or addition of surgical procedures
- History of central nervous system disorder or stroke
- History of cardiopulmonary resuscitation (CPR)
- Undergoing redo surgery (e.g., residual stenosis, bleeding)
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 |
|---|---|---|
| alpha-Tocopherolpatients in the intervention group received parenteral alpha-tocopherol at a dose of 4 mg/kg body weight | Drug | alpha-tocopherol |
| Sterile Water for Injectionthe control group received a placebo (sterile water for injection/aquabidest) | Drug | sterile water for injection |
Primary outcome
Change in Serum Troponin I Concentration (ng/L)
Time frame: Before surgery, 1 hour after surgery, and 8 hours after surgery
Serum Troponin I concentration will be measured at baseline (before surgery), 1 hour after surgery, and 8 hours after surgery to assess the extent of myocardial injury associated with cardiopulmonary bypass during Tetralogy of Fallot repair.
10 secondary outcomes
Change in Serum Malondialdehyde (MDA) Concentration (ng/mL)
Time frame: Before surgery, 1 hour after surgery, and 8 hours after surgery
Change in Serum Lactate Concentration (mmol/L)
Time frame: Before surgery, 1 hour, 6 hours, 12 hours, and 24 hours after surgery
Myocardial Injury Score (Histopathology, Scale 0-3)
Time frame: 15 minutes after release of the aortic cross-clamp
Apoptotic Index (% of Apoptotic Cardiomyocytes)
Time frame: tissue sample is collected 15 minutes after releasing the aortic cross clamp
Duration of Mechanical Ventilation (hours)
Time frame: From end of surgery until extubation
anti-cTnI
Time frame: tissue sample is collected 15 minutes after releasing the aortic cross clamp
GPx expression
Time frame: tissue sample is collected 15 minutes after releasing the aortic cross clamp
Intensive Care Unit Length of Stay (days)
Time frame: From ICU admission until ICU discharge, assessed up to 14 days
Hospital Length of Stay (days)
Time frame: From hospital admission until hospital discharge, assessed up to 30 days
Vasoactive-Inotropic Score (VIS, Scale 0-X)
Time frame: First 24 hours after surgery
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 26 Sep 2025.
- Individual participant dataSharing planned: No
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Beta-blocker Administration for Cardiomyocyte Division
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ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
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Investigation of Tetralogy of Fallot in Neonates
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RecruitingObservational study
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 alpha-Tocopherol and Sterile Water for Injection in people with Tetralogy of Fallot (TOF) and Alpha-tocopherol, run by Dr Cipto Mangunkusumo General Hospital 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 5 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 26 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
Change in Serum Troponin I Concentration (ng/L) (time frame: Before surgery, 1 hour after surgery, and 8 hours after surgery). 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 26 Sep 2025.