Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy

NCT02346123 | Completed

• 1 other identifier: CEP-41-11
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Chagas Disease

Keywords

Chagas disease; Polymorphisms; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis

  The outcome measure will be assessed within one month of follow up.

Study Arms (1)

Single group

Group which contains all the patients of the study.

Genetic: Gathering of samples of genetic material

Interventions

Gathering of samples of genetic material GENETIC

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

Single group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Sao Rafael: lead

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, Whole Blood

MeSH Terms

Conditions

Chagas Disease

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Milena BP Soares, PhD

  Hospital São Rafael

  PRINCIPAL INVESTIGATOR

• Ricardo R dos Santos, PhD

  Hospital São Rafael

  STUDY DIRECTOR

• Bruno SF Souza, MD, Msc

  Hospital São Rafael

  STUDY CHAIR

• Gabriela S Cruz, Msc

  Hospital São Rafael

  STUDY CHAIR

• Ticiana F Larocca, MD, Msc

  Hospital São Rafael

  STUDY CHAIR

• Márcia MN Rabelo, MD, Msc

  Hospital São Rafael

  STUDY CHAIR

• Luís CL Correia, MD, PhD

  Hospital São Rafael

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 26, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

BR (1)