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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Hospital Sao Rafael

Current Primary Outcome: NYHA (New York Heart Association) functional class improvement [ Time Frame: 6, 9 and 12 months after the therapy with G-CSF ]

All patients will undergo periodic clinical evaluations in order to identify improvement on NYHA classification for heart failure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assessment of cardiovascular function measured by transthoracic echocardiography [ Time Frame: 6 and 12 months after the therapy ]
    All patients will be submitted to echocardiography after 6 and 12 months to assess improvements on ventricular function.
  • Assessment of cardiovascular function measured by cardiac magnetic resonance imaging [ Time Frame: 12 months after therapy ]
    All patients will be submitted to a second cardiac magnetic resonance, after 12 months, to assess improvements on left ventricular ejection fraction.
  • Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test [ Time Frame: 12 months after the therapy ]
    All patients will be submitted to a second treadmill test and 6-minute walk test after 12 months to assess improvement on functional capacity.
  • Evaluation of improvement of quality of life [ Time Frame: 6 and 12 months after the therapy ]
    All patients will respond to Minnesota Questionnaire to have an evaluation of quality of life after 6 and 12 months.
  • Determination of tolerability [ Time Frame: 1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy ]
    All patients will be submitted to complete blood counts in several time frames in order to evaluate tolerability to G-CSF injection.


Original Secondary Outcome: Same as current

Information By: Hospital Sao Rafael

Dates:
Date Received: May 30, 2014
Date Started: September 2015
Date Completion: March 2018
Last Updated: August 16, 2016
Last Verified: August 2016