This study will look at how many children develop rheumatic heart disease (RHD) over a 3-year period. The study will include children ages 5 to 8 who do not have RHD at the start and who live in areas where the disease is common. Each child will have a heart ultrasound (echocardiogram) once a year for 3 years to check for signs of RHD. Doctors will diagnose RHD using internationally recognized guidelines from the World Heart Federation (2023). The study will also look at how often new cases occur each year, whether rates differ by age, sex, or location, and whether any children develop acute rheumatic fever during the study.
Age 5-8 years at enrollment
Residence within participating study catchment area
Parent/guardian able to provide informed consent
Participant able to provide assent where age-appropriate (country-specific, see below)
History of past ARF or RHD with or without cardiac involvement
Evidence of RHD at baseline screening
Congenital heart disease at baseline screening (excluding small PFO/ASD)
Medical conditions that would preclude safe participation or follow-up
Potential participants may be identified through locally approved school-based screening programs, community-based recruitment activities, existing demographic surveillance systems, or other locally appropriate community engagement mechanisms.
Cohort
Prospective
Not listed
Number of Participants with 3-Year Cumulative Incidence of Rheumatic Heart Disease
Proportion of participants who develop RHD during the 3-year follow-up period, defined according to the 2023 World Heart Federation (WHF) echocardiographic criteria. Participants will be considered to have reached the endpoint if RHD is identified on any follow-up echocardiogram at 12, 24, or 36 months, or if they are diagnosed with acute rheumatic fever (ARF) during follow-up.
Rate of Newly Diagnosed Rheumatic Heart Disease
Incidence of newly diagnosed RHD at each annual assessment (12, 24, and 36 months), based on the 2023 WHF echocardiographic criteria.
Number of Participants with RHD by Age Group
Cumulative incidence of RHD stratified by age at enrollment (5-6 years versus 7-8 years).
Number of Participants with RHD by Sex
Cumulative incidence of RHD stratified by participant sex.
Number of Participants with RHD by Geographic Location
Cumulative incidence of RHD stratified by study site (Uganda, Malawi, and The Gambia)
Number of Participants with Acute Rheumatic Fever
Number and proportion of participants diagnosed with acute rheumatic fever during follow-up, diagnosed according to the 2015 Revised Jones Criteria. ARF events will be monitored as a safety outcome.
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Children's Hospital Medical Center, Cincinnati
Lead sponsor
Uganda Heart Institute
Collaborator
Murdoch Childrens Research Institute
Collaborator
Ochsner Health System
Collaborator
Malawi Liverpool Wellcome Programme
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
