MicroRNAs as Biomarkers in Patients With Chagas Disease

Chagas Disease Clinical Trial

Official title:

Validation of MicroRNAs as Biomarkers for Determining Patients Prognosis With Chagas Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842880
• Other study ID #: CEP-41-10-2
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: February 19, 2015
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: February 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• 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 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chagas Disease

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	Correlation of plasmatic levels of MicroRNAs with the percentage of heart fibrosis	Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging	One year	No
Secondary	Correlation of plasmatic levels of MicroRNAs with the functional cardiovascular capacity	Mensuration of the functional capacity with treadmill test.	One year	No
Secondary	Correlation of plasmatic levels of MicroRNAs with the left ventricular function	Mensuration of the left ventricular function with echocardiogram and magnetic resonance imaging	One year	No
Secondary	Correlation of plasmatic levels of MicroRNAs with the serum levels of Pro-BNP.		One year	No
Secondary	Correlation of plasmatic levels of MicroRNAs with the serum levels of TNF-alpha		One year	No
Secondary	Correlation of plasmatic levels of MicroRNAs with the serum levels of IFN-gamma.		One year	No