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

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

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.

Study Overview

• Status: Completed
• Conditions: Chagas Cardiomyopathy; Chagas Disease

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2015
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Trypanosomiasis; Euglenozoa Infections; Cardiomyopathies; Chagas Cardiomyopathy; Chagas Disease
• Other Study ID Numbers: Holter Chagas Children

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No