Rheumatic Heart Disease School Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborator:
B.P. Koirala Institute of Health Sciences
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01550068
First received: March 7, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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
Rheumatic Heart Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Prevalence of Rheumatic Heart Disease [ Time Frame: 12 Months Screening Period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: December 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Schoolchildren aged 5-15 years from public and private schools in urban and rural area in Southeast Nepal

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Thomas Pilgrim, MD, Department of Cardiology, Bern University Hospital
ClinicalTrials.gov Identifier: NCT01550068     History of Changes
Other Study ID Numbers: 018/12
Study First Received: March 7, 2012
Last Updated: May 15, 2014
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on August 01, 2014