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

Brief Title

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

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

Rheumatic heart disease according to WHO and WHF criteria

Secondary Outcome

 Progression of disease

Condition

Rheumatic Heart Disease

Intervention

Echocardiography

Study Arms / Comparison Groups

 All study participants
Description:  Schoolgoing children 5 to 16 years of age

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

1023

Start Date

April 2014

Completion Date

July 2015

Primary Completion Date

December 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Schoolchildren aged 5 to 15 years

          -  Written informed consent

        Exclusion Criteria
      

Gender

All

Ages

5 Years - 16 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Thomas Pilgrim, MD, , 

Location Countries

Peru

Location Countries

Peru

Administrative Informations


NCT ID

NCT02353663

Organization ID

1927-CIEI_USMP-CCM


Responsible Party

Sponsor

Study Sponsor

University Hospital Inselspital, Berne

Collaborators

 Instituto de Cardiología Paredes-Horna, Arequipa

Study Sponsor

Thomas Pilgrim, MD, Principal Investigator, Bern University Hospital


Verification Date

April 2016