Clinical trial NCT04090489: Congenital Chagas Disease: Long Term Follow up of Treated Children. Preliminary Report or Cardiological Evaluation in Chagas Disease Treated Children
Official title: Post Treatment Evaluation of Terapeutic Response Biomarkers. Cardiological Studies in Children Treated for Chagas Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas Disease
Chagas Cardiomyopathy
Lead sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the efficacy of CD treatment in preventing the development of cardiac alterations in treated children.
timeFrame: 10 years
Secondary outcomes:
measure: Post treatment evaluation of treatment response biomarkers
timeFrame: 5 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Study officials:
References: