Congenital Chagas Disease: Long Term Follow up of Treated Children. Preliminary Report or Cardiological Evaluation in Chagas Disease Treated Children

NCT ID: NCT04090489

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-22
• Study Completion Date: 2020-03-01

Brief Summary

Chagas disease (CD) could be acquired by contact with the vector, transplacentally and by blood transfusion. The duration and clinical presentation of the initial acute phase of the infection may be variable, but the majority of patients are asymptomatic. The acute phase usually lasts a few months and, if untreated, the acute phase goes on to develop a chronic infection. The chronic phase usually continues for the subject's lifetime, and 30% to 40% of patients will progress to the chronic phase with a cardiac, digestive, neurological, or mixed form at 15 to 30 years after the initial infection. Progressive heart failure and sudden death due to ventricular arrhythmias are the main causes of death in patients with chronic Chagas heart disease.

Objective: To evaluate cardiac involvement in children after pharmacological treatment for Chagas disease.

Methods: Open exploratory study, blind for cardiological evaluation. Population: children treated for Chagas disease with at least 6 years after-treatment parasitological (T.cruzi qPCR), serological (IHA, EIA) and cardiological follow-up. Non-infected subjects were included as a control group for final cardiological evaluation.

Treatment: benznidazole or nifurtimox, standard dose, for 60 days. Blood samples were collected at diagnosis, end-of-treatment and every 6-12 months thereafter.

Electrocardiogram (ECG) was performed at diagnosis and every year after treatment.

In this cohort, 24 hours ECG (Holter) and Speckle-tracking strain echocardiography study were performed at the end of follow-up for this study.

Conditions

Chagas Disease; Chagas Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Chagas diseases children treated with benznidazole / or nifurtimox
• Patients with at least 6 years of after-treatment follow-up.
• Diagnosis of Chagas disease: in infants younger than 8 months by direct observation of T.cruzi using parasitological concentration method (microhematocrit test); in infants older than 9 months 2 reactive serological test (ELISA, Indirect Hemagglutination ).

Exclusion Criteria

• Patients with chronic diseases (renal, hepatic, neurological) that at the discretion of the researcher could affect the interpretation of the results.
• Subjects with congenital heart disease.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Niños R. Gutierrez de Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

Dr Jaime Altcheh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

Buenos Aires, , Argentina

Countries

Argentina

References

Gonzalez NL, Moscatelli G, Moroni S, Ballering G, Jurado L, Falk N, Bochoeyer A, Goldsman A, Grippo M, Freilij H, Garcia Bournissen F, Chatelain E, Altcheh J. Long-term cardiology outcomes in children after early treatment for Chagas disease, an observational study. PLoS Negl Trop Dis. 2022 Dec 19;16(12):e0010968. doi: 10.1371/journal.pntd.0010968. eCollection 2022 Dec.

Reference Type: DERIVED

PMID: 36534647 (View on PubMed)

Other Identifiers

Holter Chagas Children

Identifier Type: -

Identifier Source: org_study_id