An observational study in Chagas Disease and Chagas Cardiomyopathy, sponsored by Hospital de Niños R. Gutierrez de Buenos Aires. Completed at 1 site in Argentina. Open to participants aged 6 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by Hospital de Niños R. Gutierrez de Buenos Aires · Observational
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.
68 studies on the registry are indexed under Chagas Disease; 4 are open to participants now.
This study's enrollment of 120 is close to the median of 120 across 19 observational studies indexed under Chagas Disease.
Browse Chagas Disease studies →Hospital de Niños R. Gutierrez de Buenos Aires is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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).
Time frame: 10 years
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.
Time frame: 5 years
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Hospital de Niños R. Gutierrez de Buenos Aires