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Trial record 21 of 1404 for:    Peru

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

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ClinicalTrials.gov Identifier: NCT02353663
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : April 6, 2016
Sponsor:
Collaborators:
Instituto de Cardiología Paredes-Horna, Arequipa
Hospital Nacional Carlos Alberto Seguin Escobedo EsSalud
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment
Rheumatic Heart Disease Acute Rheumatic Fever Other: Echocardiography

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.


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Study Type : Observational
Actual Enrollment : 1023 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Rheumatic Heart Disease in Peru: Prevalence and Cardiovascular Outcomes Among Schoolchildren
Study Start Date : April 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort Intervention/treatment
All study participants
Schoolgoing children 5 to 16 years of age
Other: Echocardiography
Echocardiography examination




Primary Outcome Measures :
  1. Rheumatic heart disease according to WHO and WHF criteria [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Progression of disease [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Schoolchildren aged 5 to 16 years from Arequipa,Peru. Among 457 schools we randomly selected 40 classes from 20 schools using a mutlistage sampling strategy.
Criteria

Inclusion Criteria:

  • Schoolchildren aged 5 to 15 years
  • Written informed consent

Exclusion Criteria


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): NCT02353663


Locations
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Peru
Instituto de Cardiología Paredes-Horna
Arequipa, Peru, 040101
Switzerland
Department of Cardiology
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Instituto de Cardiología Paredes-Horna, Arequipa
Hospital Nacional Carlos Alberto Seguin Escobedo EsSalud
Investigators
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Principal Investigator: Thomas Pilgrim, MD Bern University Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02353663     History of Changes
Other Study ID Numbers: 1927-CIEI_USMP-CCM
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Keywords provided by University Hospital Inselspital, Berne:
Rheumatic heart disease
Rheumatic fever
Mitral regurgitation
Aortic regurgitation
Mitral stenosis
Additional relevant MeSH terms:
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Rheumatic Heart Disease
Rheumatic Fever
Rheumatic Diseases
Heart Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Arthritis
Joint Diseases