ACT4RHD is an Open-label, Randomised, Adaptive Platform Trial to Evaluate Novel and Repurposed Clinical Interventions for Patients With Acute Rheumatic Fever and Carditis. ACT4RHD Seeks to Determine Whether These Interventions Reduce RHD Severity at 6 Months.

NCT ID
NCT07830108
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
Starship Child Health, Te Toka Tumai Auckland
Conditions
Acute Rheumatic Fever, Rheumatic Fever, Rheumatic Heart Disease, Rheumatic Heart Disease in Children

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: ACT4RHD: Adaptive Collaborative Trial for Rheumatic Heart Disease

Enrollment: 600 participants (Estimated).

What is being studied

  • Intervention: Aminoquinolines
  • Intervention: Chloroquine
  • Intervention: Fused-Ring Compounds
  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 2-Ring
  • Intervention: Heterocyclic Compounds, Fused-Ring
  • Intervention: Hydroxychloroquine
  • Drug: Hydroxychloroquine (HCQ)
  • Other: No corticosteroid
  • Other: No Hydroxychloroquine (HCQ)
  • Intervention: Polycyclic Compounds
  • Intervention: Prednisolone
  • Intervention: Prednisone
  • Drug: Prednisone or Prednisolone
  • Intervention: Pregnadienediols
  • Intervention: Pregnadienes
  • Intervention: Pregnadienetriols
  • Intervention: Pregnanes
  • Intervention: Quinolines
  • Intervention: Steroids

Who may be eligible

Ages
4 Years to 25 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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).

Study locations

3 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Australia, New Zealand

  • Northern Territory, Australia: 1

Sample of listed locations

  • Royal Hospital — Darwin, Northern Territory, 0811, Australia — Site recruitment status not specified in the registry data
  • KidzFirst Hospital — Auckland, 2104, New Zealand — Site recruitment status not specified in the registry data
  • Starship Child Health, Te Toka Tumai, Auckland — Auckland, 1023, New Zealand — Site recruitment status not specified in the registry data

Study details

Start date
December 1, 2026
Primary completion date
December 1, 2034
Completion date
December 1, 2036
First posted
September 21, 2026
Collaborators
Berry Consultants, Menzies School of Health Research

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07830108
Registry last updated
October 7, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07830108 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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