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

Primary Purpose

Chronic Chagasic Myocarditis

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Treatment with G-CSF (Granulocyte colony stimulating factor)

Placebo saline

About this trial

This is an interventional treatment trial for Chronic Chagasic Myocarditis focused on measuring Chagas disease, G-CSF, Cell therapy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital São Rafael

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

G-CSF

Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02154269

First Posted

May 30, 2014

Last Updated

August 21, 2020

Sponsor

Hospital Sao Rafael

1. Study Identification

Unique Protocol Identification Number

NCT02154269

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

September 2015 (Actual)

Primary Completion Date

October 2019 (Actual)

Study Completion Date

June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Sao Rafael

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Chagasic Myocarditis

Keywords

Chagas disease, G-CSF, Cell therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

G-CSF

Arm Type

Experimental

Arm Description

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

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Treatment with G-CSF (Granulocyte colony stimulating factor)

Other Intervention Name(s)

G-CSF

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo saline

Other Intervention Name(s)

Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

NYHA (New York Heart Association) functional class improvement

Description

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 Outcome Measure Information:

Title

Assessment of cardiovascular function measured by transthoracic echocardiography

Description

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

Title

Assessment of cardiovascular function measured by cardiac magnetic resonance imaging

Description

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

Title

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

Description

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

Title

Evaluation of improvement of quality of life

Description

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

Title

Determination of tolerability

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: