Skip to main content
OpenTrials
Completed

NCT Number: NCT02154269

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Chagasic Myocarditis Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: G-CSF

Placebo saline

Drug

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

Other names: Saline

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Sao Rafael

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jun 3, 2014
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.