Rheumatic Heart Disease School Project
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|ClinicalTrials.gov Identifier: NCT01550068|
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : November 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatic Heart Disease||Diagnostic Test: Echocardiography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8519 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Population-Based Study of Prevalence of Rheumatic Heart Disease and Cardiovascular Outcomes Among Schoolchildren in Nepal|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||January 3, 2019|
|Actual Study Completion Date :||April 30, 2019|
Experimental: Experimental Arm
Diagnostic Test: Echocardiography
No Intervention: Control Arm
No echocardiographic screening
- Prevalence of Rheumatic Heart Disease [ Time Frame: 12 Months Screening Period ]
- composite of all-cause mortality, stroke, endocarditis, hospitalization for congestive heart failure, valvular surgery, mitral balloon valvuloplasty, and recurrence of rheumatic fever [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550068
|Department of Internal Medicine and Cardiology|
|B.P. Koirala Institute Of Health Sciences (bpkihs), Dharan, Nepal, 765000|
|Principal Investigator:||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)|