Cell Therapy in Chagas Cardiomyopathy

Ministry of Health, Brazil

Status and phase: Terminated; Phase 3

Conditions: Chagas Cardiomyopathy

Treatments: Drug: Standart therapy; Procedure: Stem cell; Drug: Filgrastime (G-CSF)

Study type: Interventional

Funder types: Other

Identifiers

NCT00349271

EMRTCC-CHG

Details and patient eligibility

About

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

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

182 participants in 2 patient groups

Stem Cell therapy

Experimental group

Description:

Stem Cell therapy

Treatment:

Drug: Filgrastime (G-CSF)

Procedure: Stem cell

Standart therapy

Active Comparator group

Description:

Standart therapy

Treatment:

Drug: Standart therapy