NCT07790302

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,500

participants targeted

Target at P75+ for all trials

Timeline
62mo left

Started Feb 2027

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2027

Expected
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2031

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2032

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

4.5 years

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Rheumatic Heart Disease in Children

Keywords

Rheumatic Heart DiseaseRheumatic Heart Disease in Children

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (4)

  • Rate of Newly Diagnosed Rheumatic Heart Disease

    12 months, 24 months, and 36 months

  • Number of Participants with RHD by Age Group

    3 years

  • Number of Participants with RHD by Sex

    3 years

  • Number of Participants with RHD by Geographic Location

    3 years

Other Outcomes (1)

  • Number of Participants with Acute Rheumatic Fever

    3 years

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uganda Heart Institute

Kampala, Uganda, Uganda

Location

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic FeverStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHeart DiseasesCardiovascular Diseases

Study Officials

  • Andrea Beaton

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Spaziani

CONTACT

703-347-3271aspaziani@childrensnational.org

Mary Banks

CONTACT

513-803-3123

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

July 31, 2031

Study Completion (Estimated)

March 1, 2032

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)