Rheumatic Heart Disease School Project

NCT01550068 | Completed

• 1 other identifier: 018/12
• Study Type: interventional
• Target: 8,519
• Locations: 1 country
• Sites: 1

Brief Summary

Acute rheumatic Fever (ARF) results from an autoimmune response due to molecular mimicry between the M-protein on the group A β-hemolytic streptococci (GABHS) cell membrane and cardiac myosin, and may lead through recurrent or sustained inflammation to Rheumatic Heart Disease (RHD). RHD remains a major contributor to morbidity and premature death in the working age population in Nepal. Secondary prevention with regular oral or intravenous administration of penicillin continued until early adulthood is recommended to prevent the progression of the development of endocarditis and subsequent valvular dysfunction. Screening for rheumatic heart disease using echocardiography has the potential to detect rheumatic valvular lesions at an earlier, clinically silent stage, as compared to clinical examination alone and might have a beneficial impact on long-term outcome of children with RHD. Schoolchildren aged 5-16 years from several public and private schools from rural and urban areas in Southeastern Nepal will be screened for RHD using portable echocardiography. Three main inter-related objectives will be pursued in three phases of the study: In a first phase using a cross sectional approach, the prevalence of clinical and subclinical RHD will be investigated among a representative sample of schoolchildren from public and private schools in urban and rural areas. In a second phase, using a cohort study approach among those children diagnosed at different stages of RHD, clinical outcomes with regular medical surveillance will be assessed (a), and clinical and social risk factors associated with prognosis of the disease after receiving medical care at various stages of disease at diagnosis will be determined (b). A third phase will integrate the prevalence rates from phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact of screening and RHD treatment on health resource utilization.

Conditions

Rheumatic Heart Disease

Keywords

Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Prevalence of Rheumatic Heart Disease

  12 Months Screening Period

Secondary Outcomes (1)

• composite of all-cause mortality, stroke, endocarditis, hospitalization for congestive heart failure, valvular surgery, mitral balloon valvuloplasty, and recurrence of rheumatic fever

  5 years

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Echocardiographic screening

Diagnostic Test: Echocardiography

Control Arm

NO INTERVENTION

No echocardiographic screening

Interventions

Echocardiography DIAGNOSTIC_TEST

Experimental Arm

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Schoolchildren in Southeast Nepal aged 5-16 years
• Written informed consent by the principal of the school
• Passive consent from the parents

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• B.P. Koirala Institute of Health Sciences: collaborator

Study Sites (1)

Department of Internal Medicine and Cardiology

B.P. Koirala Institute of Health Sciences (bpkihs), Dharan, 765000, Nepal

Location

Related Publications (8)

• Sadiq M, Islam K, Abid R, Latif F, Rehman AU, Waheed A, Azhar M, Khan JS. Prevalence of rheumatic heart disease in school children of urban Lahore. Heart. 2009 Mar;95(5):353-7. doi: 10.1136/hrt.2008.143982. Epub 2008 Oct 24.

  PMID: 18952636 BACKGROUND

• Carapetis JR, McDonald M, Wilson NJ. Acute rheumatic fever. Lancet. 2005 Jul 9-15;366(9480):155-68. doi: 10.1016/S0140-6736(05)66874-2.

  PMID: 16005340 BACKGROUND

• Seckeler MD, Hoke TR. The worldwide epidemiology of acute rheumatic fever and rheumatic heart disease. Clin Epidemiol. 2011 Feb 22;3:67-84. doi: 10.2147/CLEP.S12977.

  PMID: 21386976 BACKGROUND

• Marijon E, Celermajer DS, Tafflet M, El-Haou S, Jani DN, Ferreira B, Mocumbi AO, Paquet C, Sidi D, Jouven X. Rheumatic heart disease screening by echocardiography: the inadequacy of World Health Organization criteria for optimizing the diagnosis of subclinical disease. Circulation. 2009 Aug 25;120(8):663-8. doi: 10.1161/CIRCULATIONAHA.109.849190. Epub 2009 Aug 10.

  PMID: 19667239 BACKGROUND

• Pelajo CF, Lopez-Benitez JM, Torres JM, de Oliveira SK. Adherence to secondary prophylaxis and disease recurrence in 536 Brazilian children with rheumatic fever. Pediatr Rheumatol Online J. 2010 Jul 26;8:22. doi: 10.1186/1546-0096-8-22.

  PMID: 20659324 BACKGROUND

• Shrestha NR, Bruelisauer D, Uranw S, Mahato R, Sherpa K, Agrawal K, Rothenbuhler M, Karki P, Pilgrim T. Mid-term outcome of children with latent rheumatic heart disease in eastern Nepal. Open Heart. 2021 Apr;8(1):e001605. doi: 10.1136/openhrt-2021-001605.

  PMID: 33820851 DERIVED

• Karki P, Uranw S, Bastola S, Mahato R, Shrestha NR, Sherpa K, Dhungana S, Odutayo A, Gurung K, Pandey N, Agrawal K, Shah P, Rothenbuhler M, Juni P, Pilgrim T. Effectiveness of Systematic Echocardiographic Screening for Rheumatic Heart Disease in Nepalese Schoolchildren: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2021 Apr 1;6(4):420-426. doi: 10.1001/jamacardio.2020.7050.

  PMID: 33471029 DERIVED

• Pilgrim T, Kalesan B, Karki P, Basnet A, Meier B, Urban P, Shrestha NR. Protocol for a population-based study of rheumatic heart disease prevalence and cardiovascular outcomes among schoolchildren in Nepal. BMJ Open. 2012 Jun 8;2(3):e001320. doi: 10.1136/bmjopen-2012-001320. Print 2012.

  PMID: 22685225 DERIVED

MeSH Terms

Conditions

Rheumatic Heart Disease

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Thomas Pilgrim, MD

  Department of Cardiology, Bern University Hospital, Switzerland

  PRINCIPAL INVESTIGATOR

• Nikesh R Shrestha, MD, FESC

  Department of Internal Medicine and Cardiology, B.P. Koirala Institute of Health Sciences (BPKIHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: December 1, 2012
• Primary Completion: January 3, 2019
• Study Completion: April 30, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

NE (1)