Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cell Therapy in Chagas Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00349271
Recruitment Status : Terminated (Change the sample size due to smaller variance than expected)
First Posted : July 6, 2006
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Financiadora de Estudos e Projetos
Information provided by (Responsible Party):
Bernardo Rangel Tura, Ministry of Health, Brazil

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

Condition or disease Intervention/treatment Phase
Chagas Cardiomyopathy Procedure: Stem cell Drug: Filgrastime (G-CSF) Drug: Standart therapy Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy
Study Start Date : January 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. increase of the ejection fraction of the left ventricle [ Time Frame: 1 year ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349271


Locations
Layout table for location information
Brazil
INCL - National Institute of Cardiology Laranjeiras
Rio de Janeiro, Brazil, 22.240-006
Sponsors and Collaborators
Ministry of Health, Brazil
Financiadora de Estudos e Projetos
Investigators
Layout table for investigator information
Principal Investigator: Ricardo R Santos, MD,PhD Centro de pesquisa Gonzalo Muniz
Principal Investigator: Gilson Feitosa, MD Hospital Santa Isabel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bernardo Rangel Tura, Professor, Ministry of Health, Brazil
ClinicalTrials.gov Identifier: NCT00349271     History of Changes
Other Study ID Numbers: EMRTCC-CHG
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Keywords provided by Bernardo Rangel Tura, Ministry of Health, Brazil:
Chagas Cardiomyopathy
Dilated Cardiomyopathy
stem cells
Therapeutics
Randomized Controlled Trials
Additional relevant MeSH terms:
Layout table for MeSH terms
Chagas Cardiomyopathy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases