Cell Therapy in Chagas Cardiomyopathy - Full Text View

Sponsors and Collaborators:	Ministery of Health, Brazil FINEP - Financiadora de Estudos e Projetos
Information provided by:	Ministery 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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy

Drug Information available for: Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by Ministery 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 ]
Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline [ 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 ]

Estimated Enrollment:	300
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stem Cell therapy: Experimental Stem Cell therapy	Procedure: Stem cell Stem cell Drug: Filgrastime (G-CSF) Filgrastime (G-CSF)
Standart therapy: Active Comparator 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

Contacts

Contact: Antonio Carlos C de Carvalho, MD,PhD	+5521-22055422	acarlos@biof.ufrj.br
Contact: Bernardo R Tura, MD,MsC	+5521-22055422	tura@centroin.com.br

Locations

Brazil
INCL - National Institute of Cardiology Laranjeiras	Recruiting
Rio de Janeiro, Brazil, 22.240-006
Contact: Augsuto Z Bozza, MD +5521-2285-3344 ext 2288 abozza@cardiol.br
Contact: Helena F Martinho, MD +5521-2285-3344 ext 2288 hfmartino@alternex.com.br
Sub-Investigator: Helena F Martino, MD

Sponsors and Collaborators

Ministery 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:	National Institute of Cardiology ( Antonio Carlos Campos de Carvalho )
Study ID Numbers:	EMRTCC-CHG
Study First Received:	July 5, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00349271 History of Changes
Health Authority:	Brazil: Ministry of Health

Keywords provided by Ministery of Health, Brazil:

Chagas Cardiomyopathy
Dilated Cardiomyopathy
stem cells
Therapeutics
Randomized Controlled Trials

Study placed in the following topic categories:

Protozoan Infections
Heart Diseases
Dilated Cardiomyopathy
Chagas Cardiomyopathy
Cardiomyopathy, Dilated

Trypanosomiasis
Parasitic Diseases
Chagas Disease
Cardiomyopathies

Additional relevant MeSH terms:

Protozoan Infections
Heart Diseases
Chagas Cardiomyopathy
Trypanosomiasis
Cardiovascular Diseases

Parasitic Diseases
Sarcomastigophora Infections
Mastigophora Infections
Chagas Disease
Cardiomyopathies

ClinicalTrials.gov processed this record on September 11, 2009