Cell Therapy in Chagas Cardiomyopathy

Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00349271

Enrollment

182

Registered

2006-07-06

Start date

2006-01-31

Completion date

2011-12-31

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chagas Cardiomyopathy

Keywords

Chagas Cardiomyopathy, Dilated Cardiomyopathy, stem cells, Therapeutics, Randomized Controlled Trials

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.

Interventions

PROCEDUREStem cell

Stem cell

DRUGFilgrastime (G-CSF)

Filgrastime (G-CSF)

DRUGStandart therapy

All drug with clinical evidence of benefical effect in Chagas disease

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
increase of the ejection fraction of the left ventricle	1 year

Secondary

Measure	Time frame
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026