Heart Diseases Clinical Trial
Official title:
The GOAL (GwokO Adunu pa Lutino) Trial: Determining the Impact of Penicillin on Latent Rheumatic Heart Disease: A Randomized Controlled Trial in Uganda
Rheumatic heart disease (RHD) affects at least 32.9 million people, mostly children living in
low-resource settings. Long-term intramuscular benzathine penicillin G (BPG) prophylaxis is
proven to prevent progression of chronic valve changes in patients with established rheumatic
heart disease (RHD) and to allow regression of valve changes in patients with a history of
acute rheumatic fever (ARF) with mild RHD. However, in low-resource settings ARF is an
elusive diagnosis, and most patients (85%) are diagnosed only when RHD is severe and
irreversible, medications ineffective, and surgical intervention is expensive and/or
unavailable.
Identification of latent RHD might be an opportunity to substantially reduce RHD morbidity
and mortality. However, detection of latent RHD is only important if outcomes are improved.
The appropriate management of children with latent RHD is unknown and no formal
recommendations exist. While some clinicians prescribe penicillin prophylaxis for children
with latent RHD, clinical equipoise exists regarding the best practice.
To fill this gap, the investigators propose a randomized controlled trial in children with
latent RHD to evaluate the efficacy of BPG prophylaxis compared to no prophylaxis. Our
primary outcome measure is progression of valvular changes on echocardiogram at 2 years. A
sample size of 916 children is needed to detect a 50% reduction of progression (expected
range 7.5-12.5% progression in BPG-arm vs. 15%-25% progression in control-arm) with 90%
power.
AIM 1: To compare the proportion of children (aged 5-17 years) with latent RHD receiving BPG
prophylaxis who progress to worse valvular disease at 2-years compared to children not
receiving BPG prophylaxis.
Hypothesis 1: Prophylaxis with BPG will result in fewer children with latent RHD showing
progression of echocardiographic valve changes at 2 years compared to children with latent
RHD not receiving BPG prophylaxis. (The investigators expect at least a 50% relative
reduction in progression in the BPG arm: range 15%-25% control arm vs. 7.5-12.5% BPG-arm.)
AIM 2: To compare the proportion of children (aged 5-17 years) with latent RHD receiving BPG
prophylaxis who regress to improved valvular disease at 2-years compared to children not
receiving BPG prophylaxis.
Hypothesis 2: Prophylaxis with BPG will result in more children with latent RHD showing
regression of echocardiographic valve changes by 2 years compared to children with latent RHD
not receiving BPG prophylaxis. (The investigators expect at least a 50% relative increase in
regression in the BPG arm: range 10-20% control arm vs. 20-40% BPG arm.)
This study is highly significant because it will establish if BPG prophylaxis improves
outcomes for children with latent RHD. Feasibility will be ensured through the experience,
resources, community support, and accessible patient population of our investigational team.
The results of our study will have high impact, immediately informing international policy on
the standard of care for children diagnosed with latent RHD and shaping, over 2-3 years,
practical and scalable programs that could substantially decrease the global burden of RHD.
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