Cell Therapy In Dilated Cardiomyopathy

Phase 3

Completed

• Conditions: Dilated Cardiomyopathy
• Interventions: Procedure: cell; Drug: optimal therapy for cardiaca failure

• Registration Number: NCT00333827
• 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.

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-06-05
• Study First Submitted QC: 2006-06-05
• Study First Posted: 2006-06-06
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cell therapy	cell	stem cell
Optimal Therapy	optimal therapy for cardiaca failure	Optimal therapy for cardiac failure

Primary Outcome Measures

Name	Time	Method
increase of the ejection fraction of the left ventricle	6 months

Secondary Outcome Measures

Name	Time	Method
Death by any cause	1 year
Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline	1 year
Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire	6 month
Difference in NYHA functional class	6 month
Percent number of patients that reached an absolute increase of 5% in ejection fraction	1 year

Trial Locations

Locations (1)

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