Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy

Hospital Sao Rafael70 enrolled

Overview

The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in patients with chronic heart failure secondary to Chagas disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Chagasic Myocarditis

Interventions

Treatment with G-CSF (Granulocyte colony stimulating factor)DRUG

Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.

Placebo salineDRUG

Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Chagas' disease confirmed by two serological tests with different methodologies; * Diagnosis of Chagas' cardiomyopathy in NYHA functional classes II, III and IV of heart failure; * Availability and willingness to participate, given the schedule of the study; * Agreement and signing the written form. Exclusion Criteria: * Acute systemic infections * Solid neoplasms, myelodysplastic syndrome, acute or chronic myeloid leukemia, confirmed by imaging studies or past medical history; * Valvulopathies with hemodynamic consequences; * Autoimmune, pulmonary, or degenerative diseases, confirmed by imaging studies or past medical history; * Severe renal, hepatic or thyroid dysfunction, confirmed by imaging studies or past medical history; * Pregnancy (confirmed by examination of β HCG) or lactation; * Known hypersensitivity to G-CSF or to other components of the formula and / or hypersensitivity to proteins derived from E. coli.

Locations (1)

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Outcomes

Primary Outcomes

NYHA (New York Heart Association) functional class improvement

All patients will undergo periodic clinical evaluations in order to identify improvement on NYHA classification for heart failure.

Time frame: 6, 9 and 12 months after the therapy with G-CSF

Secondary Outcomes

Assessment of cardiovascular function measured by transthoracic echocardiography

All patients will be submitted to echocardiography after 6 and 12 months to assess improvements on ventricular function.

Time frame: 6 and 12 months after the therapy

Assessment of cardiovascular function measured by cardiac magnetic resonance imaging

All patients will be submitted to a second cardiac magnetic resonance, after 12 months, to assess improvements on left ventricular ejection fraction.

Time frame: 12 months after therapy

Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test

All patients will be submitted to a second treadmill test and 6-minute walk test after 12 months to assess improvement on functional capacity.

Time frame: 12 months after the therapy

Evaluation of improvement of quality of life

All patients will respond to Minnesota Questionnaire to have an evaluation of quality of life after 6 and 12 months.

Time frame: 6 and 12 months after the therapy

Determination of tolerability

All patients will be submitted to complete blood counts in several time frames in order to evaluate tolerability to G-CSF injection.

Time frame: 1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy

Data from ClinicalTrials.gov

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