Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy

Hospital Sao Rafael

Status: Completed

Conditions: Chagas Disease

Treatments: Genetic: Gathering of samples of genetic material

Study type: Observational

Funder types: Other

Identifiers

NCT02346123

CEP-41-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 1 patient group

Single group

Description:

Group which contains all the patients of the study.

Treatment:

Genetic: Gathering of samples of genetic material