Clinical trial NCT01842880: MicroRNAs as Biomarkers in Patients With Chagas Disease
Official title: Validation of MicroRNAs as Biomarkers for Determining Patients Prognosis With Chagas Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas Disease
Keywords: MicroRNAs
Chagas disease
Biomarkers
Lead sponsor: Hospital Sao Rafael
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary Hospital

Brief summary: The purpose of this study is to analyze the efficacy of MicroRNAs as biomarkers on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.

Detailed description: The patients included in the study must at first sign the written consent. They shall be accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael - Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests, including:

* Collection of Blood samples for biochemical analysis;
* Electrocardiogram;
* Holter Electrocardiogram;
* Echocardiogram;
* Treadmill Test;
* X-Ray Imaging;
* Magnetic Resonance Imaging;
* Evaluation of the quality of life through the application of questionnaires (SF 36 and the Minnesota Living With Heart Failure Questionnaire).

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 valve disease defined as aortic stenosis with a gradient of VE/Ao \> 50 mmHg
* Mitral stenosis with a valve area inferior than 1,5 cm2
* Severe or moderate 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 according to the definition of sepsis of the ACCP/SCCM (American College os Chest Physicians/Society of Critical Care Medicine)
* Current abusive use of alcohol or illicit drugs (Based on the DSM IV)
* Any other comorbidities that impact patient's survival within the next 2 years
* Liver disease in activity
* Continuous use of steroids as treatment for COPD
* Hematologic, neoplastic or bone diseases
* Homeostasis disturbances
* Inflammatory diseases or chronic infectious diseases

Primary outcomes:
measure: Correlation of plasmatic levels of MicroRNAs with the percentage of heart fibrosis
timeFrame: One year
Secondary outcomes:
measure: Correlation of plasmatic levels of MicroRNAs with the functional cardiovascular capacity
timeFrame: One year
measure: Correlation of plasmatic levels of MicroRNAs with the left ventricular function
timeFrame: One year
measure: Correlation of plasmatic levels of MicroRNAs with the serum levels of Pro-BNP.
timeFrame: One year
measure: Correlation of plasmatic levels of MicroRNAs with the serum levels of TNF-alpha
timeFrame: One year
measure: Correlation of plasmatic levels of MicroRNAs with the serum levels of IFN-gamma.
timeFrame: One year
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital São Rafael
state: Bahia
Study officials:
affiliation: Hospital São Rafael
name: Milena Botelho Pereira Soares, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital São Rafael
name: Ricardo Ribeiro dos Santos, MD
role: STUDY_DIRECTOR
affiliation: Hospital São Rafael
name: Ticiana Ferreira Larocca, MD
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Márcia Maria Noya Rabelo, MD
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Luís Cláudio Lemos Correia, MD
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Bruno Solano de Freitas Souza, MD
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Carolina Thé Macedo, MD
role: STUDY_CHAIR
affiliation: Hospital São Rafael
name: Ana Luiza Dias Angelo, PhD
role: STUDY_CHAIR
References: