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NCT Number: NCT07790302

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

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.

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Key information

Conditions

Rheumatic Heart Disease in Children Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Gram-Positive Bacterial Infections Heart Diseases Infections Rheumatic Fever Rheumatic Heart Disease Streptococcal Infections

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uganda Heart Institute

Kampala, Uganda

Location contact

Alison Spaziani

CONTACT

[email protected]

703-347-3271

Esin Nkereuwem

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants with 3-Year Cumulative Incidence of Rheumatic Heart Disease

    Time frame: 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 outcomes

  1. Rate of Newly Diagnosed Rheumatic Heart Disease

    Time frame: 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.

  2. Number of Participants with RHD by Age Group

    Time frame: 3 years

    Cumulative incidence of RHD stratified by age at enrollment (5-6 years versus 7-8 years).

  3. Number of Participants with RHD by Sex

    Time frame: 3 years

    Cumulative incidence of RHD stratified by participant sex.

  4. Number of Participants with RHD by Geographic Location

    Time frame: 3 years

    Cumulative incidence of RHD stratified by study site (Uganda, Malawi, and The Gambia)

Other outcomes

  1. Number of Participants with Acute Rheumatic Fever

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Spaziani

CONTACT

[email protected]

703-347-3271

Mary Banks

CONTACT

513-803-3123

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Malawi Liverpool Wellcome Programme
  • Murdoch Childrens Research Institute
  • Ochsner Health System
  • Uganda Heart Institute

Registry information

Official study title

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

Acronym: MEERCATS 1

Important dates

Study start
2027
Primary completion
2031
Study completion
2032
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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