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

Phase 2 Completed 70 enrolled Hospital Sao Rafael

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2015-09
Primary completion: 2019-10
Completion: 2020-06

Outcome

Missed primary endpoint

paper Frequency of primary endpoint was 78% (95% CI 0.60-0.97) vs. 66% (95% CI 0.40-0.86), p = 0.47 PMID 35757326 ↗

paper Although prevention of symptom progression could not be demonstrated in the present study PMID 35757326 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Granulocyte colony-stimulating factor	Protein / enzyme biologic	10 mg/kg	Subcutaneous