NCT02661763

Brief Summary

This study will determine the prevalence of rheumatic heart disease (RHD) in Lusaka, Zambia through school-based screening methodology using ultraportable echocardiography and a recently validated, abridged screening protocol based on World Heart Federation criteria. Children that screen positive for RHD at schools will undergo confirmatory evaluation at University Teaching Hospital (UTH), Lusaka's main referral hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,024

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

January 19, 2016

Last Update Submit

November 4, 2016

Conditions

Rheumatic Heart Disease

Keywords

Rheumatic heart disease

Outcome Measures

Primary Outcomes (1)

  • Prevalence of RHD in Lusaka schoolchildren

    Cross-sectional; the screening period is anticipated to last 5 months

Study Arms (1)

Schoolchildren in Zambia

Schoolchildren in grades 7-12 in fifteen randomly selected schools in Lusaka area

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A population of approximately 1,024 schoolchildren drawn from 15 primary and secondary schools in Lusaka, Zambia, to be screened for RHD in order to determine prevalence of the disease.

You may qualify if:

  • Schoolgoing children in Lusaka in grades 7-12 at one of the participating primary or secondary schools
  • Written parental consent
  • Written assent by children
  • Present on the day of school screening

You may not qualify if:

  • Children whose parents do not provide consent
  • Children who do not provide assent
  • Children with health problems (e.g., skin infection of the chest) that preclude performance of transthoracic echocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Teaching Hosptial

Lusaka, Zambia

Location

Related Publications (19)

  • Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005 Nov;5(11):685-94. doi: 10.1016/S1473-3099(05)70267-X.

    PMID: 16253886BACKGROUND

  • Marijon E, Ou P, Celermajer DS, Ferreira B, Mocumbi AO, Jani D, Paquet C, Jacob S, Sidi D, Jouven X. Prevalence of rheumatic heart disease detected by echocardiographic screening. N Engl J Med. 2007 Aug 2;357(5):470-6. doi: 10.1056/NEJMoa065085.

    PMID: 17671255BACKGROUND

  • Bhaya M, Panwar S, Beniwal R, Panwar RB. High prevalence of rheumatic heart disease detected by echocardiography in school children. Echocardiography. 2010 Apr;27(4):448-53. doi: 10.1111/j.1540-8175.2009.01055.x. Epub 2010 Mar 24.

    PMID: 20345448BACKGROUND

  • DiSciascio G, Taranta A. Rheumatic fever in children. Am Heart J. 1980 May;99(5):635-58. doi: 10.1016/0002-8703(80)90739-5. No abstract available.

    PMID: 6989222BACKGROUND

  • 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.

    PMID: 22371105BACKGROUND

  • Kumar R. Controlling rheumatic heart disease in developing countries. World Health Forum. 1995;16(1):47-51.

    PMID: 7873024BACKGROUND

  • Robertson KA, Volmink JA, Mayosi BM. Lack of adherence to the national guidelines on the prevention of rheumatic fever. S Afr Med J. 2005 Jan;95(1):52-6.

    PMID: 15762250BACKGROUND

  • Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9.

    PMID: 22405798BACKGROUND

  • Kaplan EL. T. Duckett Jones Memorial Lecture. Global assessment of rheumatic fever and rheumatic heart disease at the close of the century. Influences and dynamics of populations and pathogens: a failure to realize prevention? Circulation. 1993 Oct;88(4 Pt 1):1964-72. doi: 10.1161/01.cir.88.4.1964. No abstract available.

    PMID: 8403347BACKGROUND

  • 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.

    PMID: 22626741BACKGROUND

  • Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7.

    PMID: 26063472BACKGROUND

  • Zuhlke LJ, Engel ME, Nkepu S, Mayosi BM. Evaluation of a focussed protocol for hand-held echocardiography and computer-assisted auscultation in detecting latent rheumatic heart disease in scholars. Cardiol Young. 2016 Aug;26(6):1097-106. doi: 10.1017/S1047951115001857. Epub 2015 Oct 1.

    PMID: 26423122BACKGROUND

  • Engelman D, Kado JH, Remenyi B, Colquhoun SM, Watson C, Rayasidamu SC, Steer AC. Teaching focused echocardiography for rheumatic heart disease screening. Ann Pediatr Cardiol. 2015 May-Aug;8(2):118-21. doi: 10.4103/0974-2069.157024.

    PMID: 26085762BACKGROUND

  • Colquhoun SM, Carapetis JR, Kado JH, Reeves BM, Remenyi B, May W, Wilson NJ, Steer AC. Pilot study of nurse-led rheumatic heart disease echocardiography screening in Fiji--a novel approach in a resource-poor setting. Cardiol Young. 2013 Aug;23(4):546-52. doi: 10.1017/S1047951112001321. Epub 2012 Oct 8.

    PMID: 23040535BACKGROUND

  • Shmueli H, Burstein Y, Sagy I, Perry ZH, Ilia R, Henkin Y, Shafat T, Liel-Cohen N, Kobal SL. Briefly trained medical students can effectively identify rheumatic mitral valve injury using a hand-carried ultrasound. Echocardiography. 2013 Jul;30(6):621-6. doi: 10.1111/echo.12122. Epub 2013 Jan 24.

    PMID: 23347259BACKGROUND

  • Carapetis JR. The stark reality of rheumatic heart disease. Eur Heart J. 2015 May 7;36(18):1070-3. doi: 10.1093/eurheartj/ehu507. Epub 2015 Jan 12. No abstract available.

    PMID: 25583760BACKGROUND

  • 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.

    PMID: 25564396BACKGROUND

  • 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.

    PMID: 26076935BACKGROUND

  • Musuku J, Engel ME, Musonda P, Lungu JC, Machila E, Schwaninger S, Mtaja A, Mulendele E, Kavindele D, Spector J, Tadmor B, Gutierrez MM, Van Dam J, Colin L, Long A, Fishman MC, Mayosi BM, Zuhlke LJ. Prevalence of rheumatic heart disease in Zambian school children. BMC Cardiovasc Disord. 2018 Jul 3;18(1):135. doi: 10.1186/s12872-018-0871-8.

    PMID: 29969998DERIVED

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic FeverStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHeart DiseasesCardiovascular Diseases

Study Officials

  • John Musuku, Doctor

    University of Zambia / University Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Paediatrician / Cardiologist

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 22, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 8, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)