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

Rheumatic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353663
• Other study ID #: 1927-CIEI_USMP-CCM
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: April 5, 2016
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2016
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1023
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• Schoolchildren aged 5 to 15 years

• Written informed consent

Exclusion Criteria

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Rheumatic Fever
• Heart Diseases
• Rheumatic Diseases
• Rheumatic Fever
• Rheumatic Heart Disease

Intervention

Other:
• Echocardiography
Echocardiography examination

Locations

Country	Name	City	State
Peru	Instituto de Cardiología Paredes-Horna	Arequipa
Switzerland	Department of Cardiology	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	EsSalud National Hospital Carlos Alberto Seguin Escobedo, Instituto de Cardiología Paredes-Horna, Arequipa

Countries where clinical trial is conducted

Peru,  Switzerland, 

References & Publications (3)

Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005 Nov;5(11):685-94. Review. — View Citation

Pelajo CF, Lopez-Benitez JM, Torres JM, de Oliveira SK. Adherence to secondary prophylaxis and disease recurrence in 536 Brazilian children with rheumatic fever. Pediatr Rheumatol Online J. 2010 Jul 26;8:22. doi: 10.1186/1546-0096-8-22. — View Citation

Rothenbühler M, O'Sullivan CJ, Stortecky S, Stefanini GG, Spitzer E, Estill J, Shrestha NR, Keiser O, Jüni P, Pilgrim T. Active surveillance for rheumatic heart disease in endemic regions: a systematic review and meta-analysis of prevalence among children and adolescents. Lancet Glob Health. 2014 Dec;2(12):e717-26. doi: 10.1016/S2214-109X(14)70310-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rheumatic heart disease according to WHO and WHF criteria		12 months	No
Secondary	Progression of disease		3 years	No