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

Phase 2

Completed

• Conditions: Chronic Chagasic Myocarditis
• Interventions: Drug: Treatment with G-CSF (Granulocyte colony stimulating factor); Drug: Placebo saline

• Registration Number: NCT02154269
• Lead Sponsor: Hospital Sao Rafael

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-30
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-03
• Study Start: 2015-09
• Primary Completion: 2019-10
• Study Completion: 2020-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-CSF	Treatment with G-CSF (Granulocyte colony stimulating factor)	Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.
Saline	Placebo saline	Subjects will be randomly assigned to receive saline for five days, during 4 cicles.

Primary Outcome Measures

Name	Time	Method
NYHA (New York Heart Association) functional class improvement	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 Outcome Measures

Name	Time	Method
Assessment of cardiovascular function measured by transthoracic echocardiography	6 and 12 months after the therapy	All patients will be submitted to echocardiography after 6 and 12 months to assess improvements on ventricular function.
Evaluation of improvement of quality of life	6 and 12 months after the therapy	All patients will respond to Minnesota Questionnaire to have an evaluation of quality of life after 6 and 12 months.
Assessment of cardiovascular function measured by cardiac magnetic resonance imaging	12 months after therapy	All patients will be submitted to a second cardiac magnetic resonance, after 12 months, to assess improvements on left ventricular ejection fraction.
Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test	12 months after the therapy	All patients will be submitted to a second treadmill test and 6-minute walk test after 12 months to assess improvement on functional capacity.
Determination of tolerability	1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy	All patients will be submitted to complete blood counts in several time frames in order to evaluate tolerability to G-CSF injection.

Trial Locations

Locations (1)

Hospital São Rafael; 🇧🇷 Salvador, Bahia, Brazil