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OpenTrials
Completed

NCT Number: NCT02353663

Rheumatic Heart Disease in Peru: Prevalence and Cardiovascular Outcomes Among Schoolchildren

Rheumatic heart disease remains a major challenge in low and middle income countries. Early detection of clinically silent valvular lesions by screening echocardiography allows timely implementation of secondary antibiotic prevention, and may prevent progression of disease to severe valvular damage and heart failure. The objective of the study is to assess the prevalence of rheumatic heart disease among schoolchildren in Arequipa, Peru. Subsequently, the investigators will evaluate progression of disease in children with early stages of subclinical rheumatic heart disease.

The investigators will perform a population-based observational survey for rheumatic heart disease using portable echocardiography among schoolchildren aged 5 to 16 years from randomly selected public and private schools. Rheumatic heart disease will be documented both according to the modified World Health Organization definition and the echocardiographic criteria suggested by the World Heart Federation.

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Key information

About this study

Background

Rheumatic fever complicated by rheumatic heart disease continues to be a major contributor to morbidity and premature death in low- and middle-income countries where it accounts for up to a quarter of a million deaths every year. Rheumatic fever results from an autoimmune response to groups A streptococcal pharyngitis and may progress to rheumatic heart disease with cumulative exposure. Data on prevalence of rheumatic heart disease in Latin America is scarce and ranges from 1.3/1000 as assessed by cardiac auscultation to 4.1/1000 as assessed by echocardiography.

Secondary antibiotic prevention and inclusion of patients with rheumatic heart disease in a registry with close follow-up has been demonstrated to reduce the cardiovascular sequelae associated with disease progression.

The natural course of early, clinically silent stages of rheumatic heart disease is largely unknown. Disease regression has been reported in up to one third of children with early morphological valvular changes consistent with rheumatic heart disease.

Objective

The objective of the study is to assess the prevalence of rheumatic heart disease among schoolchildren in Arequipa, Peru. Subsequently, the investigators will investigate progression of disease in children with early stages of subclinical rheumatic heart disease.

Methods

The investigators will perform a population-based observational survey for rheumatic heart disease using portable echocardiography among schoolchildren aged 5 to 16 years from randomly selected public and private schools. Rheumatic heart disease will be documented both according to the modified World Health Organization definition and the echocardiographic criteria suggested by the World Heart Federation. Children diagnosed with rheumatic heart disease will be started on secondary antibiotic prevention and included into a prospective registry with longitudinal follow-up.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Schoolchildren aged 5 to 15 years
  • Written informed consent

Exclusion criteria

Treatment and study plan

echocardiography

Other

Echocardiography examination

Primary outcomes

  1. Rheumatic heart disease according to WHO and WHF criteria

    Time frame: 12 months

Secondary outcomes

  1. Progression of disease

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
  • Instituto de Cardiología Paredes-Horna, Arequipa

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Feb 3, 2015
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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