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Can two existing drugs stop rheumatic fever from scarring young hearts?

NCT ID NCT07830108

NEW Disease control Sponsor: Starship Child Health, Te Toka Tumai Auckland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are running a Phase 3 trial to see whether hydroxychloroquine or corticosteroids can reduce heart valve damage in children and young people with acute rheumatic fever. The trial enrolls about 600 participants aged 4 to 25 who are hospitalized with confirmed valve inflammation. Using an adaptive design, the team can test multiple treatments at once, stop ones that do not help, and add new options as evidence emerges. The main goal is to measure heart damage, need for heart surgery, or death at six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydroxychloroquine and corticosteroids (prednisone, prednisolone, methylprednisolone, or dexamethasone)
What this could lead to
If either treatment works, doctors could add it to standard care to limit heart valve damage from acute rheumatic fever, potentially sparing children from surgery later in life.
What could go wrong
The trial may show that neither hydroxychloroquine nor corticosteroids protects heart valves better than standard care. Corticosteroids can cause weight gain, high blood sugar, and mood changes, and hydroxychloroquine can affect vision with long-term use.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2036

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

4 to 25 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: 1. Aged ≥4 and ≤25 years old 2. Currently admitted to hospital, or hospital like setting, with the primary diagnosis of Definite or Possible Acute Rheumatic Fever (diagnosed according to the 2015 Jones Criteria) 3. Echocardiographic confirmed valvulitis during the current admission 4. If previous participation in the randomised ACT4RHD platform, then meets pre-specified criteria for re-enrolment 5. Patient expected to be able to complete protocol-required follow up assessments to 6 months post-enrolment Exclusion Criteria: 1. Presentation to current hospital was more than 10 days prior to randomisation 2. Cardiac surgery (or anticipated interhospital transfer for cardiac surgery) or death is anticipated within 72 hours from screening 3. Patient has had cardiac intervention (surgery or percutaneous) for RHD within the last 6 months 4. Previous cardiac intervention /surgery for RHD more than 6months ago, but patient has not had at least 2 post-intervention echocardiograms, including at least 1 echocardiogram more than 6months after the intervention. Each domain will have additional eligibility criteria. Refer to the appliable Domain Specific Appendix (DSA).

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Conditions

The condition(s) this trial relates to.

rheumatic fever rheumatic heart disease

As listed by the trial registrant

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

Acute rheumatic fever Rheumatic fever Rheumatic heart disease Rheumatic heart disease in children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • KidzFirst Hospital

    Auckland, 2104, New Zealand

  • Starship Child Health, Te Toka Tumai, Auckland

    Auckland, 1023, New Zealand

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