An observational study in Rheumatic Heart Disease in Children, sponsored by Children's Hospital Medical Center, Cincinnati. Not yet recruiting at 1 site in Uganda. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
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.
61 studies on the registry are indexed under Rheumatic Heart Disease; 25 are open to participants now.
This study's planned enrollment of 7,500 is above the median of 1,224 across 22 observational studies indexed under Rheumatic Heart Disease.
Browse Rheumatic Heart Disease studies →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.
Counted across the registry records on this site, refreshed daily.
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.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 3 years
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.
Time frame: 12 months, 24 months, and 36 months
Number of Participants with RHD by Age Group
Cumulative incidence of RHD stratified by age at enrollment (5-6 years versus 7-8 years).
Time frame: 3 years
Number of Participants with RHD by Sex
Cumulative incidence of RHD stratified by participant sex.
Time frame: 3 years
Number of Participants with RHD by Geographic Location
Cumulative incidence of RHD stratified by study site (Uganda, Malawi, and The Gambia)
Time frame: 3 years
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.
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Jul 2031, 53 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati →