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Rheumatic Heart Disease School Project

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ClinicalTrials.gov Identifier: NCT01550068
Recruitment Status : Recruiting
First Posted : March 9, 2012
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
Information provided by:

Study Description
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 5-15 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
Rheumatic Heart Disease

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 5476 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: A Population-Based Study of Prevalence of Rheumatic Heart Disease and Cardiovascular Outcomes Among Schoolchildren in Nepal
Study Start Date : December 2012
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Schoolchildren aged 5-15 years from public and private schools in urban and rural area in Southeast Nepal


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Schoolchildren aged 5-15 years from public and private school in urban and rural areas in Southeast Nepal
Criteria

Inclusion Criteria:

  • Schoolchildren in Southeast Nepal aged 5-15 years
  • Written informed consent by the principal of the school
  • Passive consent from the parents

Exclusion Criteria

  • No formal exclusion criteria apply
Contacts and Locations

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


Contacts
Contact: Thomas Pilgrim, MD +41 31 632 21 11 thomas.pilgrim@insel.ch
Contact: Nikesh R Shrestha, MD, FESC +977 985 204 5083 nikeshmd@gmail.com

Locations
Nepal
Department of Internal Medicine and Cardiology Recruiting
B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal, 765000
Contact: Nikesh R Shrestha, MD, FESC    +977 985 204 5083    nikeshmd@gmail.com   
Principal Investigator: Nikesh R Shrestha, MD, FESC         
Sponsors and Collaborators
University Hospital Inselspital, Berne
B.P. Koirala Institute of Health Sciences
Investigators
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)
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 21, 2017
Last Verified: September 2017

Keywords provided by University Hospital Inselspital, Berne:
Rheumatic Heart Disease

Additional relevant MeSH terms:
Heart Diseases
Rheumatic Diseases
Rheumatic Heart Disease
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rheumatic Fever
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections