Status:
COMPLETED
A Long-term Follow up Study for Patients Who Participated in the GOAL Trial (GOAL-Post)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Uganda Heart Institute
Murdoch Childrens Research Institute
Conditions:
Rheumatic Heart Disease
Eligibility:
All Genders
5-17 years
Brief 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: Comp...
Eligibility Criteria
Inclusion
- Aim 1: Group A: Children and adolescents will be eligible for Aim 1 if they (1) are a prior GOAL participant deemed by the adjudication panel to have a normal echocardiogram at the 2-year endpoint, (2) are not receiving secondary antibiotic prophylaxis, and (3) agree to participate in the study via the study's informed consent/assent process.
- Group B: Children and adolescents will be eligible for Aim 1 if they (1) have a normal echocardiogram at the start of the study, (2) Meet the age/sex/geographic match requirement (from former GOAL participants), and (3) have agreed to participate in the study via the study's informed consent/assent process.
- Aim 2: Children and adolescents will be eligible for Aim 2 if they (1) are a prior GOAL participant deemed by the adjudication panel to have persistent latent RHD on echocardiogram at the 2-year endpoint, (2) have been prescribed secondary antibiotic prophylaxis, and (3) agree to participate in the study via the study's informed consent/assent process.
- Aim 3: Children and adolescents will be eligible for Aim 3 if they are prior GOAL participants deemed by the adjudication panel to (1) have a normal echocardiogram at the 2-year endpoint (Aim 1 participants), (2) deemed by the adjudication panel to have persistent latent RHD at the 2-year endpoint (Aim 2 participants), or (3) deemed by the adjudication panel to have moderate/severe RHD at the 2-year endpoint. Aim 3 will include a separate consent/assent and participants will be able to participate in each aim independently.
Exclusion
- Aim 1: Group A: Residence or school is no longer in Gulu District or one of the surrounding districts.
- Group B: Known history of ARF or RHD, or evidence of RHD on baseline echocardiogram or structural or functional cardiac defects, other than those consistent with RHD, that were known prior to or detected through echo screening (except patent foramen ovale, small atrial septal defect, small ventricular septal defect, small patent ductus arteriosus).
- Aim 2 + 3: Residence or school is no longer in Gulu District or one of the surrounding districts.
Key Trial Info
Start Date :
January 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
1423 Patients enrolled
Trial Details
Trial ID
NCT05211024
Start Date
January 28 2022
End Date
April 30 2024
Last Update
August 27 2024
Active Locations (1)
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1
Uganda Heart Institute
Kampala, Uganda