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

NCT05211024 | Completed

• 1 other identifier: 2021-0451
• Study Type: observational
• Target: 1,423
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (2)

• Progression

  Progression of echocardiographic features of latent RHD to borderline to definite, or definite to mild or definitive to moderate/severe

  2 year endpoint

• Regression

  Regression of echocardiographic features of latent RHD

  2 year endpoint

Study Arms (3)

Aim 1: Group A

Children and adolescent who are prior GOAL participants who have a normal echocardiogram at the 2 year endpoint and are no receiving secondary antibiotic prophylaxis

Aim 1 Group B

Children and adolescent who have a normal echocardiogram at the start of the study

Aim 2

Children and adolescent who are prior GOAL participants who have persistent latent RHD on echocardiogram at the 2 year endpoint.

Drug: Penicillin G Benzathine

Interventions

Penicillin G Benzathine DRUG

Participants in Aim 2 are receiving 28 days interval BPG intramuscular injection as part of standard of care

Aim 2

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Aim 1 will enroll with normal echocardiograms after 2-years of participation in the GOAL Trial (Group A) and an appropriate number of age/sex matched controls (Group B) without echocardiographic evidence of RHD. Aim 2 will enroll participants with persistent latent RHD after 2 years of participation in the GOAL Trial. (Fig. 2).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Uganda Heart Institute: collaborator
• Murdoch Childrens Research Institute: collaborator

Study Sites (1)

Uganda Heart Institute

Kampala, Uganda

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA, RNA, serum

MeSH Terms

Conditions

Rheumatic Heart Disease

Interventions

Penicillin G Benzathine

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Andrea Z Beaton, MD

  Cincinnati Chidren's hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: January 28, 2022
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

UG (1)