[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604171":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":44,"overallOfficials":50,"centralContacts":54,"locations":60,"responsibleParty":82,"collaborators":84,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":26,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":63,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Presence of echocardiographic progression of RHD at two years","The Primary Outcome will be the presence of echocardiographic progression of RHD at two years, defined by the 2023 World Heart Federation Criteria (none, mild RHD (stage A\u002FB), or moderate\u002Fsevere RHD (stage C\u002FD).","Enrollment to the end of treatment at 2 years",[14],{"measure":15,"description":16,"timeFrame":17},"Non-inferiority among sub-groups","Number of participants who show echocardiographic progression (2023 World Heart Federation Criteria) between those with echocardiographic normalization and those with stabilized mild RHD","Enrollment to the end of 2 years participation",[19],{"measure":20,"description":21,"timeFrame":22},"Exploratory sub-analysis","Number of echocardiographic progression outcomes based on the initial type of prophylaxis during the GOALIE Trial, oral prophylaxis vs. intramuscular prophylaxis.","enrollment to the end of 2 years of participation",{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":26,"timePerspective":26,"maskingInfo":28},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":29,"maskingDescription":30,"whoMasked":31},"SINGLE","Cardiologists who make up the adjudication panel.",[32],"OUTCOMES_ASSESSOR",[34,38],{"label":35,"type":36,"description":37,"interventionNames":26},"Stop prophylaxis","NO_INTERVENTION","The intervention arm will not receive prophylaxis.",{"label":39,"type":40,"description":41,"interventionNames":42},"Continue prophylaxis","ACTIVE_COMPARATOR","The control arm will receive intramuscular benzathine benzylpenicillin G (BPG) prophylaxis (600,000 IU for children \\\u003C30kg, 1.2 million IU for children ≥30kg), every 28 days for a 2-year period. The standard of care for RHD is BPG injections which is why the control arm is continuation of monthly injections.",[43],"Drug: Secondary Prophylaxis",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":26},"DRUG","Secondary Prophylaxis","Continue standard of care with continued secondary antibiotic prophylaxis",[39],[51],{"name":52,"affiliation":5,"role":53},"Andrea Z Beaton, Dr","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":26,"email":59},"Ndate Fall, PhD","CONTACT","15135171327","ndate.fall@cchmc.org",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":26,"country":66,"countryCode":65,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Uganda Heart Institute","RECRUITING","Kampala","UG","Uganda",{"type":68,"coordinates":69},"Point",[70,71],32.58219,0.31628,{"lat":71,"lon":70},[74,78],{"name":75,"role":57,"phone":76,"phoneExt":26,"email":77},"Emmy H Okello, Dr","+256775522284","emmyoks@gmail.com",{"name":79,"role":57,"phone":80,"phoneExt":26,"email":81},"Joselyn Rwebembera, Dr","+256779010527","jrwebembera@rrcuganda.org",{"type":83,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[85,86,88],{"name":62,"class":6},{"name":87,"class":6},"Open Philanthropy",{"name":89,"class":6},"Thrasher Research Fund","100604171","phase-3-a-non-inferiority-trial-of-stopping-penicillin-in-early-rheumatic-heart-disease-goal-stop-100604171",false,"NCT07146048","A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop","GOAL-Stop","Inclusion Criteria:\n\n* Participated in GOALIE\n* Concluded GOALIE with either echocardiographic normalization or stable mild RHD\n* Between ages 5-20 years at time of enrollment\n\nExclusion Criteria:\n\n* RHD Stage C\u002FD at GOALIE end of study echocardiogram\n* Relocation to extremely distant residence or school\n* Clinically documented penicillin allergy","ALL","5 Years","20 Years",{"count":101,"type":102},922,"ESTIMATED","INTERVENTIONAL",[105],"PHASE3","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).",[108],"Rheumatic Heart Disease",[110,111,112,113],"Rheumatic heart disease","global health","secondary prophylaxis","children","2026-06-18",{"date":116,"type":117},"2026-06-22","ACTUAL",{"date":119,"type":117},"2026-03-23",{"date":121,"type":102},"2029-12-31",{"name":5,"class":6},1]