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

RECRUITINGPhase 3Sponsored by Children's Hospital Medical Center, Cincinnati
Actively Recruiting
PhasePhase 3
SponsorChildren's Hospital Medical Center, Cincinnati
Started2026-03-23
Est. completion2029-02-20
Eligibility
Age5 Years – 20 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07146048

Summary

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 outcomes differ by prior prophylaxis route (oral vs. intramuscular).

Eligibility

Age: 5 Years – 20 YearsHealthy volunteers accepted
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

Conditions2

Heart DiseaseRheumatic Heart Disease

Interventions1

Secondary Prophylaxis

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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