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A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop

RecruitingPhase 3Ages 5 Years - 20 YearsAllChildren's Hospital Medical Center, Cincinnati
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In plain words

What the trial is, and whether it could suit you

GOAL-Stop is a randomized, controlled, non-inferiority trial designed to evaluate whether discontinuing secondary antibiotic prophylaxis (SAP) is non-inferior to continuing SAP in preventing progression of rheumatic heart disease (RHD) among children and adolescents. The trial will enroll participants aged 5-20 years with previously diagnosed mild RHD who have received at least 2 years of SAP and who demonstrate either echocardiographic normalization or stability (persistent mild RHD). Participants will be randomized to either continue SAP or discontinue SAP for 2 years. The primary outcome is echocardiographic progression of RHD at 2 years, assessed by blinded adjudicators using the 2023 World Heart Federation criteria. Subgroup analyses will evaluate outcomes in participants with echocardiographic normalization versus stable mild RHD, and an exploratory analysis will assess whether out

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participated in GOALIE * Concluded GOALIE with either echocardiographic normalization or stable mild RHD * Between ages 5-20 years at time of enrollment Exclusion Criteria: * RHD Stage C/D at GOALIE end of study echocardiogram * Relocation to extremely distant residence or school * Clinically documented penicillin allergy
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What it tests

  • Secondary Prophylaxis
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Where

1 site
Uganda Heart Institute
Kampala, Uganda
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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