Rheumatic Heart Disease in Peru: Prevalence and Cardiovascular Outcomes Among Schoolchildren
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| ClinicalTrials.gov Identifier: NCT02353663 |
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Recruitment Status :
Completed
First Posted : February 3, 2015
Last Update Posted : April 6, 2016
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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 |
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 |
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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All study participants
Schoolgoing children 5 to 16 years of age
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Other: Echocardiography
Echocardiography examination |
- Rheumatic heart disease according to WHO and WHF criteria [ Time Frame: 12 months ]
- Progression of disease [ Time Frame: 3 years ]
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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 |
Inclusion Criteria:
- Schoolchildren aged 5 to 15 years
- Written informed consent
Exclusion Criteria
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
| Peru | |
| Instituto de Cardiología Paredes-Horna | |
| Arequipa, Peru, 040101 | |
| Switzerland | |
| Department of Cardiology | |
| Bern, Switzerland, 3010 | |
| Principal Investigator: | Thomas Pilgrim, MD | Bern University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital Inselspital, Berne |
| ClinicalTrials.gov Identifier: | NCT02353663 |
| 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 |
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Rheumatic heart disease Rheumatic fever Mitral regurgitation Aortic regurgitation Mitral stenosis |
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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 |