Clinical trial NCT02346123: Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy
Official title: Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas Disease
Keywords: Chagas disease
Polymorphisms
Biomarkers
Lead sponsor: Hospital Sao Rafael
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease
timeFrame: The outcome measure will be assessed within one month of follow up.
Secondary outcomes:
measure: Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis
timeFrame: The outcome measure will be assessed within one month of follow up.
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital São Rafael
state: Bahia
Study officials:
affiliation: Hospital São Rafael
name: Milena BP Soares, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital São Rafael
name: Ricardo R dos Santos, PhD
role: STUDY_DIRECTOR
affiliation: Hospital São Rafael
name: Bruno SF Souza, MD, Msc
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Gabriela S Cruz, Msc
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Ticiana F Larocca, MD, Msc
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Márcia MN Rabelo, MD, Msc
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Luís CL Correia, MD, PhD
role: STUDY_CHAIR
References: