The study will be held in 63 patients with chronic Chagas Disease and 63 healthy people
Conditions
Sponsors
CRESIB-Barcelona Centre for International Health Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients from Chagas Disease endemic areas. -Older than 18 years old and younger than 50. -With serological confirmation of the infection with two different techniques. -Indeterminate or initial cardiac form -No previously treated Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Co-morbidity: previous cardiac disease from other aetiology (ischemic, alcoholic or hypertensive), active inflammatory or immunology diseases for another agent (HBV, HCV, HIV). Hepatic disfunction (elevation of ALT, AST, GGT or bilirrubine), pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The study will take about 36 months;Main Objective: Chagas disease (CD), caused by Trypanosoma cruzi, 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.;Secondary Objective: 1. To analize the evolution patterns of molecular diagnostic techniques (conventional PCR and quantitative real-time PCR) of T. cruzi in blood, brain natriuretic factor, prothrombotic factors (prothrombotin fragment and endogenous thrombin potential), antibodies against specific proteins of the trypomastigote of T. cruzi (KMP11, HSP70, PFR2 and peptid 3973), and their correlation with alterations of the left ventricle diastolic function and segmentary contractility after antiparasitis treatment. 2.To investigate the phylogenetics of the parasite and the role of the lineages of T.cruzi in the clinical presentation and disease's progression (tissue /organ tropism may be lineage-dependant). 3. To validate the specific seric proteins as biomarkers by a Surface Enhanced Laser Desorption Ionization Time Of Flight Mass Spectrometry (SELDIToF) in a substudy.;Primary end point(s): -Statistically significant correlation among the evolution of different molecular factors and echocardiography after antiparasitic treatment -Statistically significant correlation between phylogenetics of the parasite and clinical presentation of the disease -Validation as biomarkers of specific seric proteins comparing previous studies | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Statistically significant correlation among the evolution of different molecular factors and echocardiography after antiparasitic treatment -Statistically significant correlation between phylogenetics of the parasite and clinical presentation of the disease -Validation as biomarkers of specific seric proteins comparing previous studies;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Spain
Contacts
Public ContactCRESIB
CRESIB-Barcelona Centre for International ealth Research
Outcome results
None listed