Cell Therapy In Dilated Cardiomyopathy

Ministry of Health, Brazil115 enrolled

Overview

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

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. Hypothesis: The main hypothesis of this study is that the patients who received the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5% increase in absolute left ventricle ejection fraction in comparison with the control group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

115

Conditions

Dilated Cardiomyopathy

Interventions

optimal therapy for cardiaca failureDRUG

optimal therapy for cardiaca failure

cellPROCEDURE

stem cell

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

INCL - National Institute of Cardiology Laranjeiras

Rio de Janeiro, Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

increase of the ejection fraction of the left ventricle

Time frame: 6 months

Secondary Outcomes

Death by any cause

Time frame: 1 year

Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline

Time frame: 1 year

Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire

Time frame: 6 month

Difference in NYHA functional class

Time frame: 6 month

Percent number of patients that reached an absolute increase of 5% in ejection fraction

Time frame: 1 year

Data from ClinicalTrials.gov

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