Clinical trial NCT02154269: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Chagasic Myocarditis
Keywords: Chagas disease
G-CSF
Cell therapy
Lead sponsor: Hospital Sao Rafael
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: NYHA (New York Heart Association) functional class improvement
timeFrame: 6, 9 and 12 months after the therapy with G-CSF
Secondary outcomes:
measure: Assessment of cardiovascular function measured by transthoracic echocardiography
timeFrame: 6 and 12 months after the therapy
measure: Assessment of cardiovascular function measured by cardiac magnetic resonance imaging
timeFrame: 12 months after therapy
measure: Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test
timeFrame: 12 months after the therapy
measure: Evaluation of improvement of quality of life
timeFrame: 6 and 12 months after the therapy
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
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital São Rafael
state: Bahia
Study officials:
affiliation: Hospital São Rafael
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
References:
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.