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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 : May 30, 2019
Sponsor:
Collaborator:
B.P. Koirala Institute of Health Sciences
Information provided by:
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date March 7, 2012
First Posted Date March 9, 2012
Last Update Posted Date May 30, 2019
Actual Study Start Date December 2012
Actual Primary Completion Date January 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2012)
Prevalence of Rheumatic Heart Disease [ Time Frame: 12 Months Screening Period ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01550068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 8, 2012)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rheumatic Heart Disease School Project
Official Title A Population-Based Study of Prevalence of Rheumatic Heart Disease and Cardiovascular Outcomes Among Schoolchildren in Nepal
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.

Detailed Description

Background

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) (1). RHD is reported to affect over 15 million people worldwide and remains a major contributor to morbidity and premature death in the working age population in developing countries (2). Socioeconomic determinants such as poverty, overcrowding, and malnutrition have been related to RHD. The prevalence of ARF and RHD seems to be particularly high in Southeast Asia, the Western Pacific and Africa (3). Whereas heart murmurs detected on clinical examination may indicate clinically manifest RHD, echocardiographic screening revealed ten times higher prevalence rates of RHD among schoolchildren (4) and may help diagnose RHD at an earlier, "clinically silent" stage.

Patients with a past medical history of ARF or RHD are recommended secondary prevention with regular oral or intravenous administration of penicillin continued until early adulthood.

Even though preventive measures with penicillin are inexpensive and efficient, this strategy is difficult to effectuate in developing countries with limited access to health care resources.

A recent study proved that enrolling patients with ARF and RHD in a registry with close follow-up increases compliance to treatment and thus helps in reducing the cardiovascular sequelae associated with disease progression (5).

The prevalence of RHD among schoolchildren in urban and rural areas in Nepal is largely unknown, and risk factors associated with prognosis of the disease after receiving medical care at various stages of disease at diagnosis need to be determined. Moreover, the impact of screening using echocardiography, detecting RHD at an earlier, "clinically silent" stage of RHD on health resource utilization has to be determined.

Objective

Three main inter-related objectives will be pursued in three phases of the study: In the 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 the 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, 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. The 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 quality of life and health resource utilization.

Methods

The project will employ three types of study designs performed in sequential phases: a cross sectional study (part 1), a longitudinal cohort study (part 2) and an analysis of the impact of screening, secondary prevention and treatment on health resource utilization (part 3).

  1. Part 1: Cross-Sectional Survey Schoolchildren aged 5-16 years will be screened at selected schools in the Southeast area of Nepal.
  2. Part 2: Longitudinal Cohort Study Those children with documented history of ARF and/or RHD will be included into a prospective registry and receive secondary prevention will be followed on a regular basis.
  3. Part 3: Impact of Screening and Treatment of RHD The 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.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Schoolchildren aged 5-16 years from public and private school in urban and rural areas in Southeast Nepal
Condition Rheumatic Heart Disease
Intervention Not Provided
Study Groups/Cohorts 1
Schoolchildren aged 5-16 years from public and private schools in urban and rural area in Southeast Nepal
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 27, 2019)
8519
Original Estimated Enrollment
 (submitted: March 8, 2012)
10000
Actual Study Completion Date April 30, 2019
Actual Primary Completion Date January 3, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 16 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Nepal
Removed Location Countries  
 
Administrative Information
NCT Number NCT01550068
Other Study ID Numbers 018/12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Thomas Pilgrim, MD, Department of Cardiology, Bern University Hospital
Study Sponsor University Hospital Inselspital, Berne
Collaborators 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)
PRS Account University Hospital Inselspital, Berne
Verification Date May 2019