Cell Therapy in Chagas Cardiomyopathy

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Health, Brazil
• Collaborator: Financiadora de Estudos e Projetos

Criteria

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