Cell Therapy in Chagas Cardiomyopathy - Full Text View

Sponsor:	Ministry of Health, Brazil
Collaborator:	FINEP - Financiadora de Estudos e Projetos
Information provided by:	Ministry of Health, Brazil
ClinicalTrials.gov Identifier:	NCT00349271

Purpose

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

Condition	Intervention	Phase
Chagas Cardiomyopathy	Procedure: Stem cell Drug: Filgrastime (G-CSF) Drug: Standart therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy Heart Diseases

Drug Information available for: Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by Ministry of Health, Brazil:

Primary Outcome Measures:

increase of the ejection fraction of the left ventricle [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Death by any cause within 1 year of intervention [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Difference in NYHA functional class at six months and baseline [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment:	182
Study Start Date:	January 2006
Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Stem Cell therapy Stem Cell therapy	Procedure: Stem cell Stem cell Drug: Filgrastime (G-CSF) Filgrastime (G-CSF)
Active Comparator: Standart therapy Standart therapy	Drug: Standart therapy All drug with clinical evidence of benefical effect in Chagas disease

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)
Definitive implant of pace-makers, resynchronizers and CDIs
Heart failure with symptoms initiating less than 1 year ago
Active systemic arterial hypertension or history of hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349271

Locations

Brazil
INCL - National Institute of Cardiology Laranjeiras
Rio de Janeiro, Brazil, 22.240-006

Sponsors and Collaborators

Ministry of Health, Brazil

FINEP - Financiadora de Estudos e Projetos

Investigators

Principal Investigator:	Ricardo R Santos, MD,PhD	Centro de pesquisa Gonzalo Muniz
Principal Investigator:	Gilson Feitosa, MD	Hospital Santa Isabel

More Information

No publications provided

Responsible Party:	Antonio Carlos Campos de Carvalho, National Institute of Cardiology
ClinicalTrials.gov Identifier:	NCT00349271 History of Changes
Other Study ID Numbers:	EMRTCC-CHG
Study First Received:	July 5, 2006
Last Updated:	January 24, 2010
Health Authority:	Brazil: Ministry of Health

Keywords provided by Ministry of Health, Brazil:

Chagas Cardiomyopathy
Dilated Cardiomyopathy
stem cells
Therapeutics
Randomized Controlled Trials

Additional relevant MeSH terms:

Chagas Cardiomyopathy
Cardiomyopathies
Chagas Disease
Trypanosomiasis
Euglenozoa Infections

Protozoan Infections
Parasitic Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012