Cell Therapy in Chagas Cardiomyopathy

Phase 3

Terminated

• Conditions: Chagas Cardiomyopathy
• Interventions: Drug: Standart therapy; Procedure: Stem cell; Drug: Filgrastime (G-CSF)

• Registration Number: NCT00349271
• Lead Sponsor: Ministry of Health, Brazil

Brief Summary

The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

Detailed Description

This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.

The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-06
• Primary Completion: 2010-12
• Study Completion: 2011-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Diagnosis of dilated cardiomyopathy according to WHO criteria
• Syndromic heart failure in functional class III or IV of the NYHA
• Enrollment and continuous follow-up in cardiac out-patient clinic
• Adequate medical therapy after optimization therapy
• Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule

Exclusion Criteria

• Valvular diseases, except functional mitral or tricuspid reflow
• Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
• Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
• Sustained ventricular tachycardia
• Abusive use of alcohol or illicit drugs
• Pregnancy
• Use of cardio toxic drugs
• Any co-morbidity with impact in life expectancy in 2 years
• Renal function compromised (creatinine above 2 mg/dl)
• Definitive implant of pace-makers, resynchronizers and CDIs
• Heart failure with symptoms initiating less than 1 year ago
• Active systemic arterial hypertension or history of hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stem Cell therapy	Filgrastime (G-CSF)	Stem Cell therapy
Standart therapy	Standart therapy	Standart therapy
Stem Cell therapy	Stem cell	Stem Cell therapy

Primary Outcome Measures

Name	Time	Method
increase of the ejection fraction of the left ventricle	1 year

Secondary Outcome Measures

Name	Time	Method
Death by any cause within 1 year of intervention	1 year
Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline	1 year
Difference in NYHA functional class at six months and baseline	six months
Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months	1 year

Trial Locations

Locations (1)

INCL - National Institute of Cardiology Laranjeiras; 🇧🇷 Rio de Janeiro, Brazil