Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy

Chagas Disease Clinical Trial

Official title:

Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346123
• Other study ID #: CEP-41-11
• Status: Completed
• Phase: N/A
• First received: January 20, 2015
• Last updated: October 9, 2015
• Start date: June 2015
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Hospital Sao Rafael
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiomyopathies
• Chagas Cardiomyopathy
• Chagas Disease

Intervention

Genetic:
• Gathering 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.

Locations

Country	Name	City	State
Brazil	Hospital São Rafael	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Rafael

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease	We will evaluate the presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease.	The outcome measure will be assessed within one month of follow up.	No
Secondary	Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis	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.	The outcome measure will be assessed within one month of follow up.	No