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New treatment option for Rheumatic Heart Disease
Official title A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop
ClinicalTrials.gov ID: NCT07146048
What this study is testing
What is Secondary Prophylaxis?
Secondary Prophylaxis is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for rheumatic heart disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 20
You may be able to join if
- Participated in GOALIE
- Concluded GOALIE with either echocardiographic normalization or stable mild RHD
- Between ages 5-20 years at time of enrollment
You likely can't join if
- RHD Stage C/D at GOALIE end of study echocardiogram
- Relocation to extremely distant residence or school
- Clinically documented penicillin allergy
The study team makes the final eligibility decision.
Where it's taking place
- Kampala, UG, Uganda
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kampala, UG, Uganda. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.