NCT02154269

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

Prospective, Double-blind, Randomized, Placebo-controlled Phase II Clinical Trial for Evaluation of G-CSF in Patients With Chronic Chagas Cardiomyopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Hospital Sao Rafael · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Treatment with G-CSF (Granulocyte colony stimulating factor)	Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.
DRUG	Placebo saline	Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-10-01
• Completion: 2020-06-01
• First posted: 2014-06-03
• Last updated: 2020-08-24

Locations

1 site across 1 country: Brazil