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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-CSF | Experimental | Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles. |
|
| Saline | Placebo Comparator | Subjects will be randomly assigned to receive saline for five days, during 4 cicles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6, 9 and 12 months after the therapy with G-CSF |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 and 12 months after the therapy |
| Assessment of cardiovascular function measured by cardiac magnetic resonance imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milena BP Soares, PhD | Hospital São Rafael | Principal Investigator |
| Ticiana F Larocca, MD, Msc | Hospital São Rafael | Study Director |
| 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 |
| LuÃs 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São Rafael | Salvador | Estado de Bahia | 41253-190 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35757326 | Derived | Macedo CT, Larocca TF, Noya-Rabelo M, Aras R Jr, Macedo CRB, Moreira MI, Caldas AC, Torreao JA, Monsao VMA, Souza CLM, Vasconcelos JF, Bezerra MR, Petri DP, Souza BSF, Pacheco AGF, Daher A, Ribeiro-Dos-Santos R, Soares MBP. Efficacy and Safety of Granulocyte-Colony Stimulating Factor Therapy in Chagas Cardiomyopathy: A Phase II Double-Blind, Randomized, Placebo-Controlled Clinical Trial. Front Cardiovasc Med. 2022 Jun 9;9:864837. doi: 10.3389/fcvm.2022.864837. eCollection 2022. |
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| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
| Placebo saline | Drug | Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles. |
|
|
All patients will be submitted to a second cardiac magnetic resonance, after 12 months, to assess improvements on left ventricular ejection fraction. |
| 12 months after therapy |
| 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. | 12 months after the therapy |
| 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. | 6 and 12 months after the therapy |
| 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. | 1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy |
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |