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Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy

Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02346123
Enrollment
55
Registered
2015-01-26
Start date
2015-06-30
Completion date
2015-06-30
Last updated
2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chagas Disease

Keywords

Chagas disease, Polymorphisms, Biomarkers

Brief summary

The purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1 (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination of clinical forms and in the percentage of cardiac fibrosis in patients with Chagas disease.

Detailed description

The Chagas disease, in its chronic phase, can lead to the development of cardiac arrhythmias and dilated cardiomyopathy, which can evolve to heart failure, causing great morbidity and reduction on patient's quality of life. Some patients stay asymptomatic while others develop the cardiac form of the disease (chronic chagasic cardiomyopathy), or other forms, like the digestive (megacolon and megaesophagus) and the mixed form (cardiac and digestive). The objective of this study is to analyze the association between single nucleotide polymorphisms with the clinical forms and the amount of cardiac fibrosis in patients with Chagas disease. The polymorphisms will be analyzed by real time PCR (Polymerase Chain Reaction). The genes whose polymorphisms will be analyzed are: galectin-3, SOCS-3, IL-28B, CLDN-1 and CCL5. The patients shall be accompanied in the specialized outpatient clinics for Chagas disease - Center of Biotechnology and Cell Therapy. They will be submitted to collection of blood samples for biochemical analysis and cardiac magnetic resonance imaging.

Interventions

GENETICGathering of samples of genetic material

The samples will be obtained from peripheral blood mononuclear cells and the genotyping of the polymorphisms will be done by real time PCR.

Sponsors

Hospital Sao Rafael
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Chagas disease diagnosis confirmed by 2 different serologies * Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction

Exclusion criteria

* Significant aortic stenosis * Mitral stenosis with a valve area inferior than 1,5 cm2 * Superior or moderated aortic and/or mitral regurgitation * Chronic use of immunosuppressive agents * Dialysis treatment of terminal renal failure * Fever on the last 48 hours or evidence of systemic infection in activity * Current abusive use of alcohol or illicit drugs * Any other comorbidities that impact patient's survival within the next 2 years * Liver disease in activity * Continuous use of steroids as treatment for chronic obstructive pulmonary disease * Hematologic, neoplastic or bone diseases * Homeostasis disturbances * Inflammatory diseases or chronic infectious diseases

Design outcomes

Primary

MeasureTime frameDescription
Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas diseaseThe outcome measure will be assessed within one month of follow up.We will evaluate the presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease.

Secondary

MeasureTime frameDescription
Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosisThe outcome measure will be assessed within one month of follow up.We will evaluate the presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis assessed by magnetic resonance.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026