A Long-term Follow up Study for Patients Who Participated in the GOAL Trial (GOAL-Post)
- Conditions
- Rheumatic Heart Disease
- Registration Number
- NCT05211024
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Aim 1: Group A: Children and adolescents will be eligible for Aim 1 if they (1) are a<br>prior GOAL participant deemed by the adjudication panel to have a normal echocardiogram<br>at the 2-year endpoint, (2) are not receiving secondary antibiotic prophylaxis, and (3)<br>agree to participate in the study via the study's informed consent/assent process.<br><br>Group B: Children and adolescents will be eligible for Aim 1 if they (1) have a normal<br>echocardiogram at the start of the study, (2) Meet the age/sex/geographic match<br>requirement (from former GOAL participants), and (3) have agreed to participate in the<br>study via the study's informed consent/assent process.<br><br>Aim 2: Children and adolescents will be eligible for Aim 2 if they (1) are a prior GOAL<br>participant deemed by the adjudication panel to have persistent latent RHD on<br>echocardiogram at the 2-year endpoint, (2) have been prescribed secondary antibiotic<br>prophylaxis, and (3) agree to participate in the study via the study's informed<br>consent/assent process.<br><br>Aim 3: Children and adolescents will be eligible for Aim 3 if they are prior GOAL<br>participants deemed by the adjudication panel to (1) have a normal echocardiogram at the<br>2-year endpoint (Aim 1 participants), (2) deemed by the adjudication panel to have<br>persistent latent RHD at the 2-year endpoint (Aim 2 participants), or (3) deemed by the<br>adjudication panel to have moderate/severe RHD at the 2-year endpoint. Aim 3 will include<br>a separate consent/assent and participants will be able to participate in each aim<br>independently.<br><br>Exclusion Criteria:<br><br>Aim 1: Group A: Residence or school is no longer in Gulu District or one of the<br>surrounding districts.<br><br>Group B: Known history of ARF or RHD, or evidence of RHD on baseline echocardiogram or<br>structural or functional cardiac defects, other than those consistent with RHD, that were<br>known prior to or detected through echo screening (except patent foramen ovale, small<br>atrial septal defect, small ventricular septal defect, small patent ductus arteriosus).<br><br>Aim 2 + 3: Residence or school is no longer in Gulu District or one of the surrounding<br>districts.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression;Regression
- Secondary Outcome Measures
Name Time Method