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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
Sponsor:
Collaborator:
B.P. Koirala Institute of Health Sciences
Information provided by:
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Rheumatic Heart Disease Diagnostic Test: Echocardiography Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8519 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Experimental Arm
Echocardiographic screening
Diagnostic Test: Echocardiography
No Intervention: Control Arm
No echocardiographic screening



Primary Outcome Measures :
  1. Prevalence of Rheumatic Heart Disease [ Time Frame: 12 Months Screening Period ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria

  • No formal exclusion criteria apply

Information from the National Library of Medicine

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


Locations
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Nepal
Department of Internal Medicine and Cardiology
B.P. Koirala Institute Of Health Sciences (bpkihs), Dharan, Nepal, 765000
Sponsors and Collaborators
University Hospital Inselspital, Berne
B.P. Koirala Institute of Health Sciences
Investigators
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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)

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Pilgrim, MD, Department of Cardiology, Bern University Hospital
ClinicalTrials.gov Identifier: NCT01550068     History of Changes
Other Study ID Numbers: 018/12
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Keywords provided by University Hospital Inselspital, Berne:
Rheumatic Heart Disease
Additional relevant MeSH terms:
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Rheumatic Heart Disease
Rheumatic Diseases
Heart Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rheumatic Fever
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections