Determining the Impact of Penicillin in Latent RHD: The GOAL Trial
NCT ID: NCT03346525
Last Updated: 2019-10-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
807 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-06-26
Study Completion Date
2020-11-30
Brief Summary
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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.
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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Detailed Description
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Conditions
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Rheumatic Heart Disease in Children
Latent Rheumatic Heart Disease
Rheumatic Heart Disease
Heart Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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BPG Arm
Intramuscular BPG prophylaxis (600,000 IU for children \<30kg, 1.2 million IU for children ≥30kg), every 28 days
Group Type
EXPERIMENTAL
intramuscular benzathine penicillin G (BPG) prophylaxis
Intervention Type
DRUG
Intramuscular BPG prophylaxis (600,000 IU for children \<30kg, 1.2 million IU for children ≥30kg), every 28 days.
Control Arm
No prophylaxis
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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intramuscular benzathine penicillin G (BPG) prophylaxis
Intramuscular BPG prophylaxis (600,000 IU for children \<30kg, 1.2 million IU for children ≥30kg), every 28 days.
Intervention Type
DRUG
Other Intervention Names
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benzathine penicillin G
BPG
penicillin prophylaxis
Eligibility Criteria
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Inclusion Criteria
* Children will be eligible for study participation if they are (1) between the ages of 5-17 years and (2) have a new diagnosis of latent RHD detected through primary school echo screening and confirmed by blinded consensus review. All children will be recruited from schools in Gulu District in Uganda.
Exclusion Criteria
* Patients will be excluded from the study for the following reasons:
* Known history of ARF or RHD
* Newly diagnosed RHD by echo screening consider to be "missed clinical RHD" as compared to true latent RHD including: \> mild pathological valvular regurgitation at the mitral valve or aortic valve, mitral stenosis (mean MV gradient ≥ 5mmHg) (WHF, definite B), aortic stenosis (mean AV gradient ≥ 20mmHg)
* 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).
* Prior allergic reaction to penicillin
* Any known conditions predisposing to thrombocytopenia or hypercoagulability, or other contraindications to intramuscular injection
* Any known co-morbid conditions (HIV, renal deficiencies, severe malnutrition among others) that have resulted in prescription of regular antibiotic prophylaxis
* Known history of ARF or RHD
* Newly diagnosed RHD by echo screening consider to be "missed clinical RHD" as compared to true latent RHD including: \> mild pathological valvular regurgitation at the mitral valve or aortic valve, mitral stenosis (mean MV gradient ≥ 5mmHg) (WHF, definite B), aortic stenosis (mean AV gradient ≥ 20mmHg)
* 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).
* Prior allergic reaction to penicillin
* Any known conditions predisposing to thrombocytopenia or hypercoagulability, or other contraindications to intramuscular injection
* Any known co-morbid conditions (HIV, renal deficiencies, severe malnutrition among others) that have resulted in prescription of regular antibiotic prophylaxis
Minimum Eligible Age
5 Years
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Thrasher Research Fund
OTHER
Sponsor Role
collaborator
University of Cape Town
OTHER
Sponsor Role
collaborator
Uganda Heart Institute
OTHER
Sponsor Role
collaborator
Karp Family Foundation
UNKNOWN
Sponsor Role
collaborator
Gift of Life International
OTHER
Sponsor Role
collaborator
Murdoch Childrens Research Institute
OTHER
Sponsor Role
collaborator
Children's National Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Andrea Beaton
Pediatric Cardiologist, Associate Professor of Pediatrics
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Andrea Beaton, MD
Role: PRINCIPAL_INVESTIGATOR
Cincinnati Children's
Locations
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GOAL Office
Gulu, , Uganda
Site Status
Countries
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Uganda
References
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WHO - Global Burden of Disease. 2015;2015.
Reference Type
BACKGROUND
Lue HC, Wu MH, Wang JK, Wu FF, Wu YN. Long-term outcome of patients with rheumatic fever receiving benzathine penicillin G prophylaxis every three weeks versus every four weeks. J Pediatr. 1994 Nov;125(5 Pt 1):812-6. doi: 10.1016/s0022-3476(94)70082-6.
Reference Type
BACKGROUND
Tompkins DG, Boxerbaum B, Liebman J. Long-term prognosis of rheumatic fever patients receiving regular intramuscular benzathine penicillin. Circulation. 1972 Mar;45(3):543-51. doi: 10.1161/01.cir.45.3.543. No abstract available.
Reference Type
BACKGROUND
Zhang W, Mondo C, Okello E, Musoke C, Kakande B, Nyakoojo W, Kayima J, Freers J. Presenting features of newly diagnosed rheumatic heart disease patients in Mulago Hospital: a pilot study. Cardiovasc J Afr. 2013 Mar;24(2):28-33. doi: 10.5830/CVJA-2012-076.
Reference Type
BACKGROUND
Okello E, Wanzhu Z, Musoke C, Twalib A, Kakande B, Lwabi P, Wilson NB, Mondo CK, Odoi-Adome R, Freers J. Cardiovascular complications in newly diagnosed rheumatic heart disease patients at Mulago Hospital, Uganda. Cardiovasc J Afr. 2013 Apr;24(3):80-5. doi: 10.5830/CVJA-2013-004.
Reference Type
BACKGROUND
Beaton A, Okello E, Lwabi P, Mondo C, McCarter R, Sable C. Echocardiography screening for rheumatic heart disease in Ugandan schoolchildren. Circulation. 2012 Jun 26;125(25):3127-32. doi: 10.1161/CIRCULATIONAHA.112.092312. Epub 2012 May 24.
Reference Type
BACKGROUND
Steer AC, Kado J, Wilson N, Tuiketei T, Batzloff M, Waqatakirewa L, Mulholland EK, Carapetis JR. High prevalence of rheumatic heart disease by clinical and echocardiographic screening among children in Fiji. J Heart Valve Dis. 2009 May;18(3):327-35; discussion 336.
Reference Type
BACKGROUND
Engel ME, Haileamlak A, Zuhlke L, Lemmer CE, Nkepu S, van de Wall M, Daniel W, Shung King M, Mayosi BM. Prevalence of rheumatic heart disease in 4720 asymptomatic scholars from South Africa and Ethiopia. Heart. 2015 Sep;101(17):1389-94. doi: 10.1136/heartjnl-2015-307444. Epub 2015 Jun 15.
Reference Type
BACKGROUND
Zuhlke LJ, Beaton A, Engel ME, Hugo-Hamman CT, Karthikeyan G, Katzenellenbogen JM, Ntusi N, Ralph AP, Saxena A, Smeesters PR, Watkins D, Zilla P, Carapetis J. Group A Streptococcus, Acute Rheumatic Fever and Rheumatic Heart Disease: Epidemiology and Clinical Considerations. Curr Treat Options Cardiovasc Med. 2017 Feb;19(2):15. doi: 10.1007/s11936-017-0513-y.
Reference Type
BACKGROUND
Remenyi B, Wilson N, Steer A, Ferreira B, Kado J, Kumar K, Lawrenson J, Maguire G, Marijon E, Mirabel M, Mocumbi AO, Mota C, Paar J, Saxena A, Scheel J, Stirling J, Viali S, Balekundri VI, Wheaton G, Zuhlke L, Carapetis J. World Heart Federation criteria for echocardiographic diagnosis of rheumatic heart disease--an evidence-based guideline. Nat Rev Cardiol. 2012 Feb 28;9(5):297-309. doi: 10.1038/nrcardio.2012.7.
Reference Type
BACKGROUND
Beaton A, Lu JC, Aliku T, Dean P, Gaur L, Weinberg J, Godown J, Lwabi P, Mirembe G, Okello E, Reese A, Shrestha-Astudillo A, Bradley-Hewitt T, Scheel J, Webb C, McCarter R, Ensing G, Sable C. The utility of handheld echocardiography for early rheumatic heart disease diagnosis: a field study. Eur Heart J Cardiovasc Imaging. 2015 May;16(5):475-82. doi: 10.1093/ehjci/jeu296. Epub 2015 Jan 5.
Reference Type
BACKGROUND
Weinberg J, Beaton A, Aliku T, Lwabi P, Sable C. Prevalence of rheumatic heart disease in African school-aged population: Extrapolation from echocardiography screening using the 2012 World Heart Federation Guidelines. Int J Cardiol. 2016 Jan 1;202:238-9. doi: 10.1016/j.ijcard.2015.08.128. Epub 2015 Sep 12. No abstract available.
Reference Type
BACKGROUND
Roberts K, Colquhoun S, Steer A, Remenyi B, Carapetis J. Screening for rheumatic heart disease: current approaches and controversies. Nat Rev Cardiol. 2013 Jan;10(1):49-58. doi: 10.1038/nrcardio.2012.157. Epub 2012 Nov 13.
Reference Type
BACKGROUND
Karthikeyan G. Measuring and reporting disease progression in subclinical rheumatic heart disease. Heart Asia. 2016 Nov 28;8(2):74-75. doi: 10.1136/heartasia-2016-010857. eCollection 2016. No abstract available.
Reference Type
BACKGROUND
Nascimento BR, Nunes MC, Lopes EL, Rezende VM, Landay T, Ribeiro AL, Sable C, Beaton AZ. Rheumatic heart disease echocardiographic screening: approaching practical and affordable solutions. Heart. 2016 May;102(9):658-64. doi: 10.1136/heartjnl-2015-308635. Epub 2016 Feb 18.
Reference Type
BACKGROUND
Steer AC, Romani L, Kaldor JM. Mass Drug Administration for Scabies Control. N Engl J Med. 2016 Apr 28;374(17):1690. doi: 10.1056/NEJMc1600495. No abstract available.
Reference Type
BACKGROUND
Engelman D, Okello E, Beaton A, Selnow G, Remenyi B, Watson C, Longenecker CT, Sable C, Steer AC. Evaluation of Computer-Based Training for Health Workers in Echocardiography for RHD. Glob Heart. 2017 Mar;12(1):17-23.e8. doi: 10.1016/j.gheart.2015.12.001. Epub 2016 Mar 16.
Reference Type
BACKGROUND
Ploutz M, Lu JC, Scheel J, Webb C, Ensing GJ, Aliku T, Lwabi P, Sable C, Beaton A. Handheld echocardiographic screening for rheumatic heart disease by non-experts. Heart. 2016 Jan;102(1):35-9. doi: 10.1136/heartjnl-2015-308236. Epub 2015 Oct 5.
Reference Type
BACKGROUND
Lopes EL, Beaton AZ, Nascimento BR, Tompsett A, Dos Santos JP, Perlman L, Diamantino AC, Oliveira KK, Oliveira CM, Nunes MDCP, Bonisson L, Ribeiro AL, Sable C; Programa de RastreamentO da Valvopatia Reumatica (PROVAR) investigators. Telehealth solutions to enable global collaboration in rheumatic heart disease screening. J Telemed Telecare. 2018 Feb;24(2):101-109. doi: 10.1177/1357633X16677902. Epub 2016 Nov 4.
Reference Type
BACKGROUND
Zhang W, Okello E, Nyakoojo W, Lwabi P, Mondo CK. Proportion of patients in the Uganda rheumatic heart disease registry with advanced disease requiring urgent surgical interventions. Afr Health Sci. 2015 Dec;15(4):1182-8. doi: 10.4314/ahs.v15i4.17.
Reference Type
BACKGROUND
Okello E, Longenecker CT, Beaton A, Kamya MR, Lwabi P. Rheumatic heart disease in Uganda: predictors of morbidity and mortality one year after presentation. BMC Cardiovasc Disord. 2017 Jan 7;17(1):20. doi: 10.1186/s12872-016-0451-8.
Reference Type
BACKGROUND
Beaton A, Okello E, Aliku T, Lubega S, Lwabi P, Mondo C, McCarter R, Sable C. Latent rheumatic heart disease: outcomes 2 years after echocardiographic detection. Pediatr Cardiol. 2014 Oct;35(7):1259-67. doi: 10.1007/s00246-014-0925-3. Epub 2014 May 15.
Reference Type
BACKGROUND
Beaton A, Okello E, Rwebembera J, Grobler A, Engelman D, Alepere J, Carapetis J, DeWyer A, Lwabi P, Mirabel M, Mocumbi AO, Nakitto M, Ndagire E, Nunes MCP, Omara IO, Sarnacki R, Scheel A, Wilson N, Zuhlke L, Karthikeyan G, Sable CA, Steer AC. Refining Risk Stratification Among Children With Latent Rheumatic Heart Disease. Circulation. 2023 Jun 13;147(24):1848-1850. doi: 10.1161/CIRCULATIONAHA.122.063194. Epub 2023 Jun 12. No abstract available.
Reference Type
DERIVED
Beaton A, Okello E, Rwebembera J, Grobler A, Engelman D, Alepere J, Canales L, Carapetis J, DeWyer A, Lwabi P, Mirabel M, Mocumbi AO, Murali M, Nakitto M, Ndagire E, Nunes MCP, Omara IO, Sarnacki R, Scheel A, Wilson N, Zimmerman M, Zuhlke L, Karthikeyan G, Sable CA, Steer AC. Secondary Antibiotic Prophylaxis for Latent Rheumatic Heart Disease. N Engl J Med. 2022 Jan 20;386(3):230-240. doi: 10.1056/NEJMoa2102074. Epub 2021 Nov 13.
Reference Type
DERIVED
Scheel A, Mirabel M, Nunes MCP, Okello E, Sarnacki R, Steer AC, Engelman D, Zimmerman M, Zuhlke L, Sable C, Beaton A. The inter-rater reliability and individual reviewer performance of the 2012 world heart federation guidelines for the echocardiographic diagnosis of latent rheumatic heart disease. Int J Cardiol. 2021 Apr 1;328:146-151. doi: 10.1016/j.ijcard.2020.11.013. Epub 2020 Nov 10.
Reference Type
DERIVED
Beaton A, Okello E, Engelman D, Grobler A, Scheel A, DeWyer A, Sarnacki R, Omara IO, Rwebembera J, Sable C, Steer A. Determining the impact of Benzathine penicillin G prophylaxis in children with latent rheumatic heart disease (GOAL trial): Study protocol for a randomized controlled trial. Am Heart J. 2019 Sep;215:95-105. doi: 10.1016/j.ahj.2019.06.001. Epub 2019 Jun 8.
Reference Type
DERIVED
Other Identifiers
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E.W. "Al" Thrasher Award
Identifier Type: OTHER
Identifier Source: secondary_id
GOAL: RHD RCT
Identifier Type: -
Identifier Source: org_study_id
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