Abstract Body (Do not enter title and authors here): Background: The current standard for children diagnosed with rheumatic heart disease (RHD) is secondary antibiotic prophylaxis (SAP) for at least 10 years or to a minimum age of 21. However, these recommendations were developed prior to the widespread use of echocardiography and based largely on expert opinion. A recent clinical trial in Uganda found that up to 50% of children with early RHD show echocardiographic normalization by 2 years. More research is needed to understand if continued SAP is needed after echocardiographic normalization.

Hypothesis: There is a low risk of RHD recurrence in individuals who have had normalization of their echocardiogram following early RHD diagnosis.

Aim: To determine the 2-year safety of not providing SAP to children and adolescents with early RHD who have shown echocardiographic normalization.

Methods: The GOAL trial in Uganda, 2018-2021, compared SAP with Benzathine Penicillin G (BPG) to no prophylaxis among children with early RHD. GOAL-Post is a non-randomized prospective extension study of the GOAL Trial. Children with echocardiographic normalization at the end of GOAL, regardless of treatment arm, were followed prospectively without SAP, for 2 additional years. Echocardiograms were performed at the end of follow-up, uploaded to a cloud server, and interpreted by a four-person adjudication panel. Recurrence was determined by side-by-side comparison with GOAL enrollment and completion studies.

Results: Of 345 eligible participants, 330 (96%) were enrolled, mean age 16 years (SD = 2.3), 56% female, and all completed the two-year follow-up. Only one of 330 (0.3%) progressed to moderate/severe RHD after the 2 years, and an additional 26 participants (7.9%) had evidence of mild RHD, which was clinically comparable to their cardiac status at the start of the GOAL Trial. No participants had clinical signs or symptoms of RHD and no documented rheumatic fever. This means that 99% of children and adolescents who had echocardiographic normalization were safe from moderate/severe RHD and 92% were safe from any RHD, without SAP.

Conclusion: These findings suggest that it may be safe to consider stopping of SAP among children who show echocardiographic normalization, providing more individualized recommendations for SAP duration, rather than the current model of long-term SAP for all. Further study is needed including a stoppage of SAP trial, to generate higher quality evidence for this approach.