NCT05211024

A Long-term Follow up Study for Patients Who Participated in the GOAL Trial (GOAL-Post)

A Follow-up Study for Patients Who Participated in the GOAL Trial (GOAL-Post)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,423 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Accepted

Summary

GOAL-Post is comprised of two studies that will help refine recommendations for the duration of secondary prophylaxis for children diagnosed with latent RHD, which is currently not known

Detailed description

GOAL-Post is comprised of two studies that will help refine recommendations for the duration of secondary prophylaxis for children diagnosed with latent RHD, which is currently not known. Aim 1: Compare the two-year risk of developing RHD (borderline or definite) between children and adolescents who completed the GOAL Trial with a normal echocardiogram (prior diagnosis of latent RHD) and age/sex/and geographically matched controls with repeated normal echocardiograms (normal in both the original GOAL screening in 2017/2018 and in the planned GOAL-Post screening in 2021). Aim 2: Determine the five-year rate of RHD progression and regression among children with persistent latent RHD who receive secondary antibiotic prophylaxis (medium-term impact of prophylaxis). Five years includes time from initial GOAL enrollment to the end of GOAL-Post. Aim 3: Create a RHD biobank that will support further research on RHD genetic susceptibility and pathophysiology

Conditions

• Rheumatic Heart Disease

Interventions

Type	Name	Description
DRUG	Penicillin G Benzathine	Participants in Aim 2 are receiving 28 days interval BPG intramuscular injection as part of standard of care

Timeline

• Start date: 2022-01-28
• Primary completion: 2024-03-30
• Completion: 2024-04-30
• First posted: 2022-01-27
• Last updated: 2024-08-27

Locations

1 site across 1 country: Uganda