Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
115 participants
INTERVENTIONAL
2006-01-31
2013-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Optimal Therapy
Optimal therapy for cardiac failure
optimal therapy for cardiaca failure
optimal therapy for cardiaca failure
cell therapy
stem cell
cell
stem cell
Interventions
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optimal therapy for cardiaca failure
optimal therapy for cardiaca failure
cell
stem cell
Eligibility Criteria
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Inclusion 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Financiadora de Estudos e Projetos
OTHER
Ministry of Health, Brazil
OTHER_GOV
Responsible Party
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Bernardo Rangel Tura
Professor
Principal Investigators
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Antonio Carlos C de Carvalho, MD,PhD
Role: STUDY_DIRECTOR
INCL
Bernardo R Tura, Md,MsC
Role: STUDY_CHAIR
INCL
Augusto Z Bozza, MD
Role: PRINCIPAL_INVESTIGATOR
INCL
Locations
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INCL - National Institute of Cardiology Laranjeiras
Rio de Janeiro, Rio de Janeiro, Brazil
Countries
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References
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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-blind trial of intracoronary autologous mononuclear bone marrow cell injection in non-ischaemic dilated cardiomyopathy (the dilated cardiomyopathy arm of the MiHeart study). Eur Heart J. 2015 Nov 7;36(42):2898-904. doi: 10.1093/eurheartj/ehv477. Epub 2015 Sep 20.
Other Identifiers
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EMRTCC-MCD
Identifier Type: -
Identifier Source: org_study_id
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