Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Chagasic Myocarditis

Keywords

Chagas diseaseG-CSFCell 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 salineDrug

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

Eligibility Criteria

Age20 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Hospital Sao Rafael
Otherlead

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

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: 35757326DERIVED

MeSH Terms

Conditions

Chagas Disease

Interventions

TherapeuticsGranulocyte Colony-Stimulating FactorSodium Chloride

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugates

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

Enrollment

70 participants (actual enrollment reported by the registry).

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 2015

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

G-CSF

Saline

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

G-CSF

Saline

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations