NCT02353663

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,023

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

8 months

First QC Date

January 28, 2015

Last Update Submit

April 5, 2016

Conditions

Rheumatic Heart DiseaseAcute Rheumatic Fever

Keywords

Rheumatic heart diseaseRheumatic feverMitral regurgitationAortic regurgitationMitral stenosis

Outcome Measures

Primary Outcomes (1)

  • Rheumatic heart disease according to WHO and WHF criteria

    12 months

Secondary Outcomes (1)

  • Progression of disease

    3 years

Study Arms (1)

All study participants

Schoolgoing children 5 to 16 years of age

Other: Echocardiography

Interventions

EchocardiographyOTHER

Echocardiography examination

All study participants

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Schoolchildren aged 5 to 15 years
  • Written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto de Cardiología Paredes-Horna

Arequipa, Arequipa, 040101, Peru

Location

Department of Cardiology

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (5)

  • Rothenbuhler M, O'Sullivan CJ, Stortecky S, Stefanini GG, Spitzer E, Estill J, Shrestha NR, Keiser O, Juni 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.

    PMID: 25433627BACKGROUND

  • 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. doi: 10.1016/S1473-3099(05)70267-X.

    PMID: 16253886BACKGROUND

  • 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.

    PMID: 20659324BACKGROUND

  • Bartkowiak J, Spitzer E, Kurmann R, Zurcher F, Krahenmann P, Garcia-Ruiz V, Mercado J, Ryffel C, Losdat S, Llerena N, Torres P, Lanz J, Stocker M, Ren B, Glockler M, Pilgrim T. The impact of obesity on left ventricular hypertrophy and diastolic dysfunction in children and adolescents. Sci Rep. 2021 Jun 22;11(1):13022. doi: 10.1038/s41598-021-92463-x.

    PMID: 34158575DERIVED

  • Spitzer E, Mercado J, Islas F, Rothenbuhler M, Kurmann R, Zurcher F, Krahenmann P, Llerena N, Juni P, Torres P, Pilgrim T. Screening for Rheumatic Heart Disease among Peruvian Children: A Two-Stage Sampling Observational Study. PLoS One. 2015 Jul 24;10(7):e0133004. doi: 10.1371/journal.pone.0133004. eCollection 2015.

    PMID: 26208006DERIVED

MeSH Terms

Conditions

Rheumatic Heart DiseaseRheumatic FeverMitral Valve InsufficiencyAortic Valve InsufficiencyMitral Valve Stenosis

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHeart DiseasesCardiovascular DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesHeart Valve DiseasesAortic Valve Disease

Study Officials

  • Thomas Pilgrim, MD

    Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 3, 2015

Study Start

April 1, 2014

Primary Completion

December 1, 2014

Study Completion

July 1, 2015

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

PE(1)CH(1)