Valvular & structural heart disease
Intramuscular versus enteral penicillin prophylaxis to prevent progression of rheumatic heart disease: Study protocol for a noninferiority randomized trial (the GOALIE trial)
Study context
- Population
- Ugandan children aged 5 to 17 years with mild Rheumatic Heart Disease (RHD) (Stage A or B, 2023 World Heart Federation criteria) identified by echocardiographic screeningplanned sample size
- Participants
- 1,004 children
- Planned comparison
- Oral penicillin V vs intramuscular BPG secondary prophylaxis
- Primary endpoint
- Proportion of children progressing to more advanced RHD
- Follow-up
- 2 years
Methodological detailsnon-inferiority, blinded echocardiography adjudication panel, Non-inferiority margin 4%, 90% power, allowing 7% loss to follow-up, Enrollment commenced October 2023; final follow-up expected December 2026
- Non-inferiority
- Blinded echocardiography adjudication panel
- Non-inferiority margin 4%, 90% power, allowing 7% loss to follow-up
- Enrollment commenced October 2023; final follow-up expected December 2026
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Intramuscular versus enteral penicillin prophylaxis to prevent progression of rheumatic heart disease: Study protocol for a noninferiority randomized trial (the GOALIE trial). Am Heart J. Published 24 May 2024. doi:10.
Summarised from the published abstract; every number is checked against it