Rheumatic Heart DiseaseNCT05211024
A Long-term Follow up Study for Patients Who Participated in the GOAL Trial (GOAL-Post)
An observational study of Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
Trial 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 Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease
- What is being tested?
- Penicillin G Benzathine
- Type of treatment
- Injection or infusion
- How many people
- 1,423 participants
- Where
- 1 siteUganda
- Study dates
- 28 Jan 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Follow-up Study for Patients Who Participated in the GOAL Trial (GOAL-Post)
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
Read the 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
- Being tested
- Penicillin G Benzathine
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penicillin G BenzathineDrug
Participants in Aim 2 are receiving 28 days interval BPG intramuscular injection as part of standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Penicillin G Benzathine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression
Progression of echocardiographic features of latent RHD to borderline to definite, or definite to mild or definitive to moderate/severe
Measured: 2 year endpoint
Regression
Regression of echocardiographic features of latent RHD
Measured: 2 year endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start28 Jan 2022
- Primary completion30 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Heart Institute, Murdoch Childrens Research Institute
- Responsible party
- Sponsor
- Investigators
- Andrea Z Beaton, MD, Principal investigator, Cincinnati Chidren's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211024
- Sponsor's protocol ID
- 2021-0451
- Status last verified
- Aug 2024
- First submitted
- 14 Jan 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study for Patients Who Participated in the GOAL Trial (GOAL-Post)
- ClinicalTrials.gov ID
- NCT05211024
- Acronym / sponsor ID
- 2021-0451
- Conditions
- Rheumatic Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,423 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Uganda Heart Institute, Murdoch Childrens Research Institute
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: Penicillin G BenzathineChildren and adolescent who are prior GOAL participants who have persistent latent RHD on echocardiogram at the 2 year endpoint. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penicillin G BenzathineParticipants in Aim 2 are receiving 28 days interval BPG intramuscular injection as part of standard of care | Drug | Aim 2 |
Primary outcome
Progression
Time frame: 2 year endpoint
Progression of echocardiographic features of latent RHD to borderline to definite, or definite to mild or definitive to moderate/severe
Regression
Time frame: 2 year endpoint
Regression of echocardiographic features of latent RHD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Z Beaton, MD principal investigator
Cincinnati Chidren's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression (time frame: 2 year endpoint). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.