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

NCT04090489 | Completed

• 1 other identifier: Holter Chagas Children
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of CD treatment in preventing the development of cardiac alterations in treated children.

  To compare number of patients with pathological cardiac findings, measured by Holter and ECG, in two different groups: patients with treated Chagas disease (either with Nifurtimox or Benznidazole) and healthy (without Chagas disease) patients of the same population (control group).

  10 years

Secondary Outcomes (1)

• Post treatment evaluation of treatment response biomarkers

  5 years

Eligibility Criteria

• Age: 6 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of CD treated children with at least 6 years post-treatment parasitological (T. cruzi qPCR), serological and cardiological follow-up. Treatment: benznidazole (Bz) or nifurtimox (Nftx), standard dose, for 60 days.

You may qualify if:

• 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 ).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Niños R. Gutierrez de Buenos Aires: lead

Study Sites (1)

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

Buenos Aires, 1425, Argentina

Location

Related Publications (1)

• 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.

  PMID: 36534647 DERIVED

MeSH Terms

Conditions

Chagas Disease; Chagas Cardiomyopathy

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 16, 2019
• Study Start: January 22, 2015
• Primary Completion: November 1, 2019
• Study Completion: March 1, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

AR (1)