Congenital Chagas Disease: Long Term Follow up of Treated Children. Preliminary Report or Cardiological Evaluation in Chagas Disease Treated Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04090489|
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : April 24, 2020
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.
|Condition or disease|
|Chagas Disease Chagas Cardiomyopathy|
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||Post Treatment Evaluation of Terapeutic Response Biomarkers. Cardiological Studies in Children Treated for Chagas Disease|
|Actual Study Start Date :||January 22, 2015|
|Actual Primary Completion Date :||November 1, 2019|
|Actual Study Completion Date :||March 1, 2020|
- To evaluate the efficacy of CD treatment in preventing the development of cardiac alterations in treated children. [ 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).
- Post treatment evaluation of treatment response biomarkers [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090489
|Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires|
|Buenos Aires, Argentina, 1425|