Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03346525
Study type Interventional
Source Children's Research Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date June 26, 2018
Completion date November 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT04624412 - Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2 N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT04561908 - Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access N/A
Active, not recruiting NCT06190743 - Perception of Cardiovascular Risk
Completed NCT04580095 - Artificial Intelligence for Improved Echocardiography N/A
Completed NCT04562636 - Evaluating a Messaging Campaign in the United States N/A
Recruiting NCT03277365 - MyGeneRank: A Digital Platform for Next-Generation Genetic Studies N/A
Active, not recruiting NCT05553106 - Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Recruiting NCT04390672 - Multivessel TALENT N/A
Enrolling by invitation NCT03314818 - Natural History of Carotid Plaque as Determined by 3D Ultrasound N/A
Withdrawn NCT03289104 - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02046902 - Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Completed NCT01944254 - The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients N/A
Completed NCT01909349 - Web-based Aftercare Intervention for Cardiac Patients N/A
Recruiting NCT01457586 - Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery Phase 4
Recruiting NCT01207167 - Mediators of Atherosclerosis in South Asians Living in America
Recruiting NCT01541163 - Heart and Ischemic STrOke Relationship studY N/A
Terminated NCT00968383 - Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment N/A