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

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ClinicalTrials.gov Identifier: NCT02154269
Recruitment Status : Enrolling by invitation
First Posted : June 3, 2014
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Milena Botelho Pereira Soares, 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.

Condition or disease Intervention/treatment Phase
Chronic Chagasic Myocarditis Drug: Treatment with G-CSF (Granulocyte colony stimulating factor) Drug: Placebo saline Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Double-blind, Randomized, Placebo-controlled Phase II Clinical Trial for Evaluation of G-CSF in Patients With Chronic Chagas Cardiomyopathy
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Experimental: G-CSF
Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.
Drug: 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.
Other Name: G-CSF

Placebo Comparator: Saline
Subjects will be randomly assigned to receive saline for five days, during 4 cicles.
Drug: Placebo saline
Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.
Other Name: Saline




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Assessment of cardiovascular function measured by transthoracic echocardiography [ Time Frame: 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.

  2. Assessment of cardiovascular function measured by cardiac magnetic resonance imaging [ Time Frame: 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.

  3. Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test [ Time Frame: 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.

  4. Evaluation of improvement of quality of life [ Time Frame: 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.

  5. Determination of tolerability [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154269


Locations
Brazil
Hospital São Rafael
Salvador, Bahia, Brazil, 41253-190
Sponsors and Collaborators
Hospital Sao Rafael
Investigators
Principal Investigator: Milena BP Soares, PhD Hospital São Rafael
Study Director: Ticiana F Larocca, MD, Msc Hospital São Rafael
Study Chair: Ricardo Ribeiro-dos-Santos, PhD Hospital São Rafael
Study Chair: Bruno SF Souza, MD, Msc Hospital São Rafael
Study Chair: Márcia MN Rabelo, MD, Msc Hospital São Rafael
Study Chair: Luís Cláudio L Correia, MD, Msc Hospital São Rafael
Study Chair: Carolina T Macedo, MD, Msc Hospital São Rafael
Study Chair: Clarissa LM Souza, MD Hospital São Rafael

Responsible Party: Milena Botelho Pereira Soares, PhD, Hospital Sao Rafael
ClinicalTrials.gov Identifier: NCT02154269     History of Changes
Other Study ID Numbers: PCL07/12
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

Keywords provided by Milena Botelho Pereira Soares, Hospital Sao Rafael:
Chagas disease
G-CSF
Cell therapy

Additional relevant MeSH terms:
Myocarditis
Cardiomyopathies
Chagas Cardiomyopathy
Heart Diseases
Cardiovascular Diseases
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs