New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease

Barcelona Centre for International Health Research63 enrolled

Overview

Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chagas Disease

Interventions

BenznidazoleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients from endemic areas (Latin America) * Older than 18 years old and younger than 50 * With serological confirmation of Chagas Disease infection with two different techniques * Indeterminate or initial cardiac form * No previously treated for Chagas Disease Exclusion Criteria: * Co-morbidity: previous cardiac disease from other aetiology (ischemic, alcoholic or hypertensive), active inflammatory or immunology diseases for another agent. Hepatic disfunction * Pregnancy or lactation

Locations (1)

International Health Department, Hospital Clinic, Barcelona

Barcelona, Catalonia, Spain

Outcomes

Primary Outcomes

Biomarkers for prognosis, early diagnosis and effectiveness of treatment.

* Conventional polymerase chain reaction of T. cruzi in blood * Measurement of Brain natriuretic factor * Measurement of Prothrombotic factors * Measurement of antibodies against specific proteins of the trypomastigote of T. cruzi * Investigation of the phylogenetics of the parasite and the role of the lineages of T.cruzi in the clinical presentation and disease's progression

Time frame: 2 years

Secondary Outcomes

Cardiac function after antiparasitic treatment

\- Correlation between biomarkers and alterations of the left ventricle diastolic function and segmentary contractility after antiparasitic treatment

Time frame: 2 years

Data from ClinicalTrials.gov

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