ACT4RHD
Improving treatment for acute rheumatic fever and rheumatic heart disease
The ACT4RHD Trial
ACT4RHD is an international adaptive platform trial investigating treatments for acute rheumatic fever to prevent lasting heart damage in children and young people.
Primary outcome:
To assess the severity of rheumatic heart disease six months after enrolment, including heart valve damage, the need for cardiac surgery, and survival.
Primary outcome:
Address a critical gap in treatment evidence for a condition that disproportionately affects Māori and Pacific communities in New Zealand and Aboriginal and Torres Strait Islander communities in Australia.
In Aotearoa New Zealand, the burden is highly inequitable. In 2024, there were 149 confirmed or probable first episodes of rheumatic fever, with 124 occurring among children and young people aged 5–24. Rates were 24.1 per 100,000 for Pacific peoples and 6.9 per 100,000 for Māori, compared with 0.1 per 100,000 for European and other ethnicities.
Ministry of Health NZAustralia experiences similar inequities. In 2024, 506 acute rheumatic fever diagnoses were recorded across reporting jurisdictions, with Aboriginal and Torres Strait Islander people accounting for 93% of diagnoses. The highest rate was among First Nations children aged 5–14, at 110.8 diagnoses per 100,000. AIHW
Acute rheumatic fever can develop following a Group A Streptococcus infection. The body's immune response can cause inflammation and damage to the heart valves, leading to rheumatic heart disease and potentially lifelong health consequences.
Background
These inequities reflect longstanding differences in housing, living conditions and access to timely healthcare. Despite the serious consequences of the disease, evidence about which anti-inflammatory treatments can prevent lasting heart damage remains limited.
Trial design
ACT4RHD is a Phase 3 adaptive platform trial designed to investigate multiple treatments within a shared research framework.
The trial will initially evaluate two treatment approaches: corticosteroids and hydroxychloroquine. Each will be compared with care that does not include the relevant study treatment, alongside standard clinical care.
The trial aims to recruit 600 children and young people aged 4–25 years.
Participants will be screened for eligibility, consented and randomised to the treatment groups relevant to them.
Researchers will collect clinical information at baseline, discharge, and follow-up, including laboratory results and echocardiograms to assess heart health and valve damage.
The adaptive design allows researchers to evaluate new treatments and make planned changes as evidence becomes available, supporting the trial as it evolves.
Key connections
“I find my day-to-day work with Spiral so purposeful and interesting - I feel really engaged with what we’re trying to achieve.””
Spiral’s contribution
Our Spiral Project Lead for the ACT4RHD Trial is Mel Booth
From managing sprints to building wireframes, working with developers, to liaising with the client, Mel is able to draw heavily upon her project management experience to get her projects out the door. She enjoys being immersed in the medical industry and the technical challenges that come with it.