Rheumatic Heart DiseaseNCT02353663
Rheumatic Heart Disease in Peru: Prevalence and Cardiovascular Outcomes Among Schoolchildren
An observational study of Rheumatic Heart Disease and Acute Rheumatic Fever, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease, Acute Rheumatic Fever
- What is being tested?
- Echocardiography
- How many people
- 1,023 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Schoolchildren aged 5 to 15 years
- Written informed consent
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- Conditions
- Rheumatic Heart Disease, Acute Rheumatic Fever
- Being tested
- Echocardiography
- Keywords
- Rheumatic heart disease, Rheumatic fever, Mitral regurgitation, Aortic regurgitation, Mitral stenosis
- Medical subject headings
- Rheumatic Heart Disease, Rheumatic Fever, Mitral Valve Insufficiency, Aortic Valve Insufficiency, Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
Echocardiography examination
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Schoolgoing children 5 to 16 years of age Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatic heart disease according to WHO and WHF criteria
Measured: 12 months
Secondary outcomes (1)
Progression of disease
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Cardiología Paredes-Horna, Arequipa, Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
- Responsible party
- Sponsor
- Investigators
- Thomas Pilgrim, MD, Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353663
- Sponsor's protocol ID
- 1927-CIEI_USMP-CCM
- Status last verified
- Apr 2016
- First submitted
- 28 Jan 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25433627Carapetis 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.
PubMed 16253886Pelajo 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.
PubMed 20659324Bartkowiak 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.
PubMed 34158575Spitzer 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.
PubMed 26208006
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatic Heart Disease in Peru: Prevalence and Cardiovascular Outcomes Among Schoolchildren
- ClinicalTrials.gov ID
- NCT02353663
- Acronym / sponsor ID
- 1927-CIEI_USMP-CCM
- Conditions
- Rheumatic Heart Disease, Acute Rheumatic Fever
- Keywords
- Rheumatic heart disease, Rheumatic fever, Mitral regurgitation, Aortic regurgitation, Mitral stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Instituto de Cardiología Paredes-Horna, Arequipa, Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | Other: EchocardiographySchoolgoing children 5 to 16 years of age |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Schoolchildren aged 5 to 15 years
- Written informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyEchocardiography examination | Other | All study participants |
Primary outcome
Rheumatic heart disease according to WHO and WHF criteria
Time frame: 12 months
1 secondary outcome
Progression of disease
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Background: PubMed 25433627Rothenbuhler 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.
- Background: PubMed 16253886Carapetis 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.
- Background: PubMed 20659324Pelajo 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.
- Derived from this study: PubMed 34158575Bartkowiak 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.
- Derived from this study: PubMed 26208006Spitzer 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.
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Rheumatic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Pilgrim, MD principal investigator
Bern University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Heart Disease and Acute Rheumatic Fever, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rheumatic heart disease according to WHO and WHF criteria (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02353663, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.