A Phase 3 interventional study of Secondary Prophylaxis in Rheumatic Heart Disease, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in Uganda. Open to participants aged 5 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 3, Interventional, and Treatment
Among 13 studies in Rheumatic Heart Disease by Children's Hospital Medical Center, Cincinnati — 7 open to participants now, 7 under way, 2 of them phase 3. Rheumatic Heart Disease · Children's Hospital Medical Center, Cincinnati.
Among the 13 studies in Rheumatic Heart Disease by Children's Hospital Medical Center, Cincinnati, this one is the 5th largest by planned enrollment of the 10 interventional ones that give a count, is one of 4 that started in 2026, is one of 2 in phase 3, and was the 7th registered.
61 studies on the registry are indexed under Rheumatic Heart Disease; 25 are open to participants now.
Browse Rheumatic Heart Disease studies →7 of the 13 studies in Rheumatic Heart Disease by Children's Hospital Medical Center, Cincinnati are open now, in 2 countries. Recruiting first, the newest first:
Children's Hospital Medical Center, Cincinnati · Sites in Uganda
Ages 5+
Children's Hospital Medical Center, Cincinnati · Sites in Uganda
Ages 5–8 · Healthy volunteers
Children's Hospital Medical Center, Cincinnati · Sites in Uganda
Ages 5–8
Children's Hospital Medical Center, Cincinnati · Sites in Uganda
Healthy volunteers
Children's Hospital Medical Center, Cincinnati · Sites in United States
By country, each count listing its studies:
Of the 11 Rheumatic Heart Disease studies recruiting now, 5 (45%) set no upper age limit and 5 (45%) stop at 75 or younger; 8 take children under 18; 4 take healthy volunteers.
This study: 5 Years to 20 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2022; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 922 is above the median of 221 across 37 interventional studies indexed under Rheumatic Heart Disease.
Median enrollment 629 across the 10 interventional studies, 1,423 across the 3 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
1 of the studies in Rheumatic Heart Disease by Children's Hospital Medical Center, Cincinnati that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05783375Children's Hospital Medical Center, CincinnatiAccelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda | 2027-01-31 |
Among the 13 studies in Rheumatic Heart Disease by Children's Hospital Medical Center, Cincinnati, from their registry updates:
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The intervention arm will not receive prophylaxis.
The control arm will receive intramuscular benzathine benzylpenicillin G (BPG) prophylaxis (600,000 IU for children \<30kg, 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.
Drug: Secondary Prophylaxis
Continue standard of care with continued secondary antibiotic prophylaxis
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/B), or moderate/severe RHD (stage C/D).
Time frame: Enrollment to the end of treatment at 2 years
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
Time frame: Enrollment to the end of 2 years participation
Exploratory sub-analysis
Number of echocardiographic progression outcomes based on the initial type of prophylaxis during the GOALIE Trial, oral prophylaxis vs. intramuscular prophylaxis.
Time frame: enrollment to the end of 2 years of participation
Plan to share: Undecided — Pending approval of consent form
Started Mar 2026 (actual). Primary completion is estimated for Feb 2029, 34 months after the start.
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