Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy

October 9, 2015 updated by: Milena Botelho Pereira Soares, Hospital Sao Rafael
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 41253-190
        • Hospital Sao Rafael

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Tertiary Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single group
Group which contains all the patients of the study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease
Time Frame: The 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.
The outcome measure will be assessed within one month of follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis
Time Frame: The 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.
The outcome measure will be assessed within one month of follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Rafael

Investigators

  • Study Director: Ricardo R dos Santos, PhD, Hospital Sao Rafael
  • Study Chair: Gabriela S Cruz, Msc, Hospital Sao Rafael
  • Study Chair: Luís CL Correia, MD, PhD, Hospital Sao Rafael

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (ESTIMATE)

January 26, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 9, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP-41-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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