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Vitamin e shot may shield young hearts during complex surgery

NCT ID NCT07194304

Disease control Sponsor: Dr Cipto Mangunkusumo General Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving vitamin E (alpha-tocopherol) during heart surgery could reduce heart muscle damage in children with Tetralogy of Fallot, a birth defect. 58 children aged 1-10 years received either vitamin E or a placebo at the start of surgery. The main goal was to see if vitamin E lowered troponin I levels, a marker of heart injury, after the operation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

60 people

The number who actually took part.

Started

May 2022

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 10 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

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Conditions

The condition(s) this trial relates to.

tetralogy of fallot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alpha-tocopherol Cardiac surgery Tetralogy of fallot (TOF)

Contacts and locations

Locations

  • Cipto Mangunkusumo Hospital

    Jakarta, Indonesia

More trials for these conditions

Other studies related to the condition(s) this trial covers.