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

Chagas Disease Clinical Trial

Official title:

Post Treatment Evaluation of Terapeutic Response Biomarkers. Cardiological Studies in Children Treated for Chagas Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090489
• Other study ID #: Holter Chagas Children
• Status: Completed
• Start date: January 22, 2015
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Hospital de Niños R. Gutierrez de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Chagas Cardiomyopathy
• Chagas Disease

Locations

Country	Name	City	State
Argentina	Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Niños R. Gutierrez de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post treatment evaluation of treatment response biomarkers	To compare serology titles in patients treated for Chagas disease (either with Nifurtimox or Benznidazole) with PCR titles in the same group of patients and evaluate if PCR can be an early marker of therapeutic response compared to serology.	5 years