Rheumatic Heart Disease School Project
NCT01550068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8519
Last updated 2019-11-13
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
Interventions
- DIAGNOSTIC_TEST
-
Echocardiography
Sponsors & Collaborators
-
B.P. Koirala Institute of Health Sciences
collaborator OTHER -
Insel Gruppe AG, University Hospital Bern
lead OTHER
Principal Investigators
-
Thomas Pilgrim, MD · Department of Cardiology, Bern University Hospital, Switzerland
-
Nikesh R Shrestha, MD, FESC · Department of Internal Medicine and Cardiology, B.P. Koirala Institute of Health Sciences (BPKIHS)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2019-01-03
- Completion
- 2019-04-30
Countries
- Nepal
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