Rheumatic Heart Disease School Project

NCT01550068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8519

Last updated 2019-11-13

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01550068 on ClinicalTrials.gov