Multi-country Evaluation of Early RHD in Children Across Africa for Vaccine Trial Readiness

A Multinational Cohort Study to Determine the Incidence of Early Rheumatic Heart Disease (MEERCATS Study 1)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07790302

Acronym

MEERCATS 1

Enrollment

7500

Registered

2026-08-27

Start date

2027-02-01

Completion date

2032-03-01

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic Heart Disease in Children

Keywords

Rheumatic Heart Disease, Rheumatic Heart Disease in Children

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 8 Years

Healthy volunteers

Inclusion criteria

* 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) * Normal baseline echocardiogram according to study screening protocol

Exclusion criteria

* 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 * Anticipated inability to complete study follow-up

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with 3-Year Cumulative Incidence of Rheumatic Heart Disease	3 years	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.

Secondary

Measure	Time frame	Description
Rate of Newly Diagnosed Rheumatic Heart Disease	12 months, 24 months, and 36 months	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	3 years	Cumulative incidence of RHD stratified by age at enrollment (5-6 years versus 7-8 years).
Number of Participants with RHD by Sex	3 years	Cumulative incidence of RHD stratified by participant sex.
Number of Participants with RHD by Geographic Location	3 years	Cumulative incidence of RHD stratified by study site (Uganda, Malawi, and The Gambia)

Countries

Uganda

Contacts

CONTACTAlison Spaziani

aspaziani@childrensnational.org703-347-3271

CONTACTMary Banks

513-803-3123

PRINCIPAL_INVESTIGATORAndrea Beaton

Children's Hospital Medical Center, Cincinnati

Outcome results