Rheumatic Heart Disease in ChildrenMEERCATS 1NCT07790302
Multi-country Evaluation of Early RHD in Children Across Africa for Vaccine Trial Readiness
An observational study of Rheumatic Heart Disease in Children, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Rheumatic Heart Disease in Children
- How many people
- 7,500 participants
- Where
- 1 siteUganda
- Study dates
- Feb 2027to 1 Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mary Banks contact
Uganda1 site
Uganda Heart Institute
Kampala, Uganda
Alison Spaziani, 703-347-3271, aspaziani@childrensnational.org
Esin Nkereuwem
About this study
Official title: A Multinational Cohort Study to Determine the Incidence of Early Rheumatic Heart Disease (MEERCATS Study 1)
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.
- Conditions
- Rheumatic Heart Disease in Children
- Keywords
- Rheumatic Heart Disease, Rheumatic Heart Disease in Children
- Medical subject headings
- Rheumatic Heart Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (4)
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.
Measured: 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).
Measured: 3 years
Number of Participants with RHD by Sex
Cumulative incidence of RHD stratified by participant sex.
Measured: 3 years
Number of Participants with RHD by Geographic Location
Cumulative incidence of RHD stratified by study site (Uganda, Malawi, and The Gambia)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startFeb 2027 (estimated)
- Primary completion31 Jul 2031 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Heart Institute, Murdoch Childrens Research Institute, Ochsner Health System, Malawi Liverpool Wellcome Programme
- Responsible party
- Sponsor
- Investigators
- Andrea Beaton, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790302
- Sponsor's protocol ID
- 2026-0637
- Acronym
- MEERCATS 1
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational Cohort Study to Determine the Incidence of Early Rheumatic Heart Disease (MEERCATS Study 1)
- ClinicalTrials.gov ID
- NCT07790302
- Acronym / sponsor ID
- MEERCATS 1 / 2026-0637
- Conditions
- Rheumatic Heart Disease in Children
- Keywords
- Rheumatic Heart Disease, Rheumatic Heart Disease in Children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Uganda Heart Institute, Murdoch Childrens Research Institute, Ochsner Health System, Malawi Liverpool Wellcome Programme
- Study start
- Feb 2027 (estimated)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Rate of Newly Diagnosed Rheumatic Heart Disease
Time frame: 12 months, 24 months, and 36 months
Number of Participants with RHD by Age Group
Time frame: 3 years
Number of Participants with RHD by Sex
Time frame: 3 years
Number of Participants with RHD by Geographic Location
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Rheumatic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Banks contact
Andrea Beaton principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Heart Disease in Children, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Spaziani (703-347-3271, aspaziani@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with 3-Year Cumulative Incidence of Rheumatic Heart Disease (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.