Cell Therapy In Dilated Cardiomyopathy

Dilated Cardiomyopathy Clinical Trial

Official title:

Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333827
• Other study ID #: EMRTCC-MCD
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2006
• Last updated: March 9, 2017
• Start date: January 2006
• Est. completion date: February 2013

Study information

• Verified date: March 2017
• Source: Ministry of Health, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Drug:
• optimal therapy for cardiaca failure
optimal therapy for cardiaca failure

Procedure:
• cell
stem cell

Locations

Country	Name	City	State
Brazil	INCL - National Institute of Cardiology Laranjeiras	Rio de Janeiro

Sponsors (2)

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

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Martino H, Brofman P, Greco O, Bueno R, Bodanese L, Clausell N, Maldonado JA, Mill J, Braile D, Moraes J Jr, Silva S, Bozza A, Santos B, Campos de Carvalho A; Dilated Cardiomyopathy Arm of the MiHeart Study Investigators.. Multicentre, randomized, double- — View Citation

Outcome

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

External Links

•   Original article