Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Buenos Aires, 1425, Argentina
NCT Number: NCT04090489
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.
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Notify Me6 year–50 year
All sexes
Observational
Buenos Aires, 1425, Argentina
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 years
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: 5 years
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.
Hospital de Niños R. Gutierrez de Buenos Aires
Other
Post Treatment Evaluation of Terapeutic Response Biomarkers. Cardiological Studies in Children Treated for Chagas Disease
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