Prospective, Double-blind, Randomized, Placebo-controlled Phase II Clinical Trial for Evaluation of G-CSF in Patients With Chronic Chagas Cardiomyopathy

Hospital Sao Rafael1 site in 1 country70 target enrollmentSeptember 2015

ConditionsChronic Chagasic Myocarditis

InterventionsTreatment with G-CSF (Granulocyte colony stimulating factor)Placebo saline

DrugsTreatment with G-CSF (Granulocyte colony stimulating factor)Placebo saline

Overview

Phase: Phase 2
Intervention: Treatment with G-CSF (Granulocyte colony stimulating factor)
Conditions: Chronic Chagasic Myocarditis
Sponsor: Hospital Sao Rafael
Enrollment: 70
Locations: 1
Primary Endpoint: NYHA (New York Heart Association) functional class improvement
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

June 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Sao Rafael

Responsible Party

Principal Investigator

Milena Botelho Pereira Soares

PhD

Hospital Sao Rafael

Eligibility Criteria

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.

Arms & Interventions

G-CSF

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

Intervention: Treatment with G-CSF (Granulocyte colony stimulating factor)

Saline

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

Intervention: Placebo saline

Outcomes

Primary Outcomes

NYHA (New York Heart Association) functional class improvement

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

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

Secondary Outcomes

Assessment of cardiovascular function measured by transthoracic echocardiography(6 and 12 months after the therapy)
Evaluation of improvement of quality of life(6 and 12 months after the therapy)
Assessment of cardiovascular function measured by cardiac magnetic resonance imaging(12 months after therapy)
Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test(12 months after the therapy)
Determination of tolerability(1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy)