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

NCT02154269 | Completed Phase 2 DMC

• 1 other identifier: PCL07/12
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Chagasic Myocarditis

Keywords

Chagas disease; G-CSF; Cell therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Assessment of cardiovascular function measured by transthoracic echocardiography

  6 and 12 months after the therapy

• Assessment of cardiovascular function measured by cardiac magnetic resonance imaging

  12 months after therapy

• Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test

  12 months after the therapy

• Evaluation of improvement of quality of life

  6 and 12 months after the therapy

• Determination of tolerability

  1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy

Study Arms (2)

G-CSF

EXPERIMENTAL

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)

Saline

PLACEBO COMPARATOR

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

Drug: Placebo saline

Interventions

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.

Also known as: G-CSF

G-CSF

Placebo saline DRUG

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

Also known as: Saline

Saline

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Sao Rafael: lead

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Related Publications (1)

• 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.

  PMID: 35757326 DERIVED

MeSH Terms

Conditions

Chagas Disease

Interventions

Therapeutics; Granulocyte Colony-Stimulating Factor; Sodium Chloride

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• 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

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: September 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: June 1, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

BR (1)