Clinical trial NCT00333827: Cell Therapy In Dilated Cardiomyopathy
Official title: Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dilated Cardiomyopathy
Keywords: Dilated Cardiomyopathy
stem cells
Therapeutics
Randomized Controlled Trials
Lead sponsor: Ministry of Health, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: Financiadora de Estudos e Projetos
First posted: 2006-06-06
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: increase of the ejection fraction of the left ventricle
timeFrame: 6 months
Secondary outcomes:
measure: Death by any cause
timeFrame: 1 year
measure: Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline
timeFrame: 1 year
measure: Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire
timeFrame: 6 month
measure: Difference in NYHA functional class
timeFrame: 6 month
measure: Percent number of patients that reached an absolute increase of 5% in ejection fraction
timeFrame: 1 year
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: INCL - National Institute of Cardiology Laranjeiras
Study officials:
affiliation: INCL
name: Antonio Carlos C de Carvalho, MD,PhD
role: STUDY_DIRECTOR
affiliation: INCL
name: Bernardo R Tura, Md,MsC
role: STUDY_CHAIR
affiliation: INCL
name: Augusto Z Bozza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.