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 ]
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