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Cell Therapy in Chagas Cardiomyopathy

Primary Purpose

Chagas Cardiomyopathy

Status
Terminated
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Stem cell
Filgrastime (G-CSF)
Standart therapy
Sponsored by
Ministry of Health, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chagas Cardiomyopathy focused on measuring Chagas Cardiomyopathy, Dilated Cardiomyopathy, stem cells, Therapeutics, Randomized Controlled Trials

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • INCL - National Institute of Cardiology Laranjeiras

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stem Cell therapy

Standart therapy

Arm Description

Stem Cell therapy

Standart therapy

Outcomes

Primary Outcome Measures

increase of the ejection fraction of the left ventricle

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2006
Last Updated
March 9, 2017
Sponsor
Ministry of Health, Brazil
Collaborators
Financiadora de Estudos e Projetos
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1. Study Identification

Unique Protocol Identification Number
NCT00349271
Brief Title
Cell Therapy in Chagas Cardiomyopathy
Official Title
Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Change the sample size due to smaller variance than expected
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Brazil
Collaborators
Financiadora de Estudos e Projetos

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Cardiomyopathy
Keywords
Chagas Cardiomyopathy, Dilated Cardiomyopathy, stem cells, Therapeutics, Randomized Controlled Trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem Cell therapy
Arm Type
Experimental
Arm Description
Stem Cell therapy
Arm Title
Standart therapy
Arm Type
Active Comparator
Arm Description
Standart therapy
Intervention Type
Procedure
Intervention Name(s)
Stem cell
Intervention Description
Stem cell
Intervention Type
Drug
Intervention Name(s)
Filgrastime (G-CSF)
Intervention Description
Filgrastime (G-CSF)
Intervention Type
Drug
Intervention Name(s)
Standart therapy
Intervention Description
All drug with clinical evidence of benefical effect in Chagas disease
Primary Outcome Measure Information:
Title
increase of the ejection fraction of the left ventricle
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Death by any cause within 1 year of intervention
Time Frame
1 year
Title
Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline
Time Frame
1 year
Title
Difference in NYHA functional class at six months and baseline
Time Frame
six months
Title
Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo R Santos, MD,PhD
Organizational Affiliation
Centro de pesquisa Gonzalo Muniz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gilson Feitosa, MD
Organizational Affiliation
Hospital Santa Isabel
Official's Role
Principal Investigator
Facility Information:
Facility Name
INCL - National Institute of Cardiology Laranjeiras
City
Rio de Janeiro
ZIP/Postal Code
22.240-006
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22523306
Citation
Ribeiro Dos Santos R, Rassi S, Feitosa G, Grecco OT, Rassi A Jr, da Cunha AB, de Carvalho VB, Guarita-Souza LC, de Oliveira W Jr, Tura BR, Soares MB, Campos de Carvalho AC; Chagas Arm of the MiHeart Study Investigators. Cell therapy in Chagas cardiomyopathy (Chagas arm of the multicenter randomized trial of cell therapy in cardiopathies study): a multicenter randomized trial. Circulation. 2012 May 22;125(20):2454-61. doi: 10.1161/CIRCULATIONAHA.111.067785. Epub 2012 Apr 20.
Results Reference
derived

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Cell Therapy in Chagas Cardiomyopathy

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