Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT02154269
Status:
COMPLETED
Last Update Posted:
2020-08-24
First Post:
2014-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014355', 'term': 'Chagas Disease'}], 'ancestors': [{'id': 'D014352', 'term': 'Trypanosomiasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-21', 'studyFirstSubmitDate': '2014-05-30', 'studyFirstSubmitQcDate': '2014-06-02', 'lastUpdatePostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NYHA (New York Heart Association) functional class improvement', 'timeFrame': '6, 9 and 12 months after the therapy with G-CSF', 'description': 'All patients will undergo periodic clinical evaluations in order to identify improvement on NYHA classification for heart failure.'}], 'secondaryOutcomes': [{'measure': 'Assessment of cardiovascular function measured by transthoracic echocardiography', 'timeFrame': '6 and 12 months after the therapy', 'description': 'All patients will be submitted to echocardiography after 6 and 12 months to assess improvements on ventricular function.'}, {'measure': 'Assessment of cardiovascular function measured by cardiac magnetic resonance imaging', 'timeFrame': '12 months after therapy', 'description': 'All patients will be submitted to a second cardiac magnetic resonance, after 12 months, to assess improvements on left ventricular ejection fraction.'}, {'measure': 'Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test', 'timeFrame': '12 months after the therapy', '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.'}, {'measure': 'Evaluation of improvement of quality of life', 'timeFrame': '6 and 12 months after the therapy', 'description': 'All patients will respond to Minnesota Questionnaire to have an evaluation of quality of life after 6 and 12 months.'}, {'measure': 'Determination of tolerability', 'timeFrame': '1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy', 'description': 'All patients will be submitted to complete blood counts in several time frames in order to evaluate tolerability to G-CSF injection.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chagas disease', 'G-CSF', 'Cell therapy'], 'conditions': ['Chronic Chagasic Myocarditis']}, 'referencesModule': {'references': [{'pmid': '35757326', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Chagas' disease confirmed by two serological tests with different methodologies;\n* Diagnosis of Chagas' cardiomyopathy in NYHA functional classes II, III and IV of heart failure;\n* Availability and willingness to participate, given the schedule of the study;\n* Agreement and signing the written form.\n\nExclusion Criteria:\n\n* Acute systemic infections\n* Solid neoplasms, myelodysplastic syndrome, acute or chronic myeloid leukemia, confirmed by imaging studies or past medical history;\n* Valvulopathies with hemodynamic consequences;\n* Autoimmune, pulmonary, or degenerative diseases, confirmed by imaging studies or past medical history;\n* Severe renal, hepatic or thyroid dysfunction, confirmed by imaging studies or past medical history;\n* Pregnancy (confirmed by examination of β HCG) or lactation;\n* Known hypersensitivity to G-CSF or to other components of the formula and / or hypersensitivity to proteins derived from E. coli."}, 'identificationModule': {'nctId': 'NCT02154269', 'briefTitle': 'Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Sao Rafael'}, 'officialTitle': 'Prospective, Double-blind, Randomized, Placebo-controlled Phase II Clinical Trial for Evaluation of G-CSF in Patients With Chronic Chagas Cardiomyopathy', 'orgStudyIdInfo': {'id': 'PCL07/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G-CSF', 'description': 'Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.', 'interventionNames': ['Drug: Treatment with G-CSF (Granulocyte colony stimulating factor)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Subjects will be randomly assigned to receive saline for five days, during 4 cicles.', 'interventionNames': ['Drug: Placebo saline']}], 'interventions': [{'name': 'Treatment with G-CSF (Granulocyte colony stimulating factor)', 'type': 'DRUG', 'otherNames': ['G-CSF'], 'description': 'Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.', 'armGroupLabels': ['G-CSF']}, {'name': 'Placebo saline', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41253-190', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital São Rafael', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Milena BP Soares, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Ticiana F Larocca, MD, Msc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Ricardo Ribeiro-dos-Santos, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Bruno SF Souza, MD, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Márcia MN Rabelo, MD, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Luís Cláudio L Correia, MD, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Carolina T Macedo, MD, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}, {'name': 'Clarissa LM Souza, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital São Rafael'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Sao Rafael', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Milena Botelho Pereira Soares', 'investigatorAffiliation': 'Hospital Sao Rafael'}}}}