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

  • STATUS
    Recruiting
  • End date
    Jun 16, 2024
  • participants needed
    1102
  • sponsor
    Children's Hospital Medical Center, Cincinnati
Updated on 16 March 2022
antibiotic
Accepts healthy volunteers

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

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

Details
Condition Rheumatic Heart Disease
Treatment penicillin G benzathine
Clinical Study IdentifierNCT05211024
SponsorChildren's Hospital Medical Center, Cincinnati
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
-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
-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 Criteria

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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