- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00349271
Cell Therapy in Chagas Cardiomyopathy
Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Rio de Janeiro, Brazil, 22.240-006
- INCL - National Institute of Cardiology Laranjeiras
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stem Cell therapy
|
Stem cell
Filgrastime (G-CSF)
|
Active Comparator: Standart therapy
|
All drug with clinical evidence of benefical effect in Chagas disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
increase of the ejection fraction of the left ventricle
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death by any cause within 1 year of intervention
Time Frame: 1 year
|
1 year
|
Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline
Time Frame: 1 year
|
1 year
|
Difference in NYHA functional class at six months and baseline
Time Frame: six months
|
six months
|
Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ricardo R Santos, MD,PhD, Centro de pesquisa Gonzalo Muniz
- Principal Investigator: Gilson Feitosa, MD, Hospital Santa Isabel
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMRTCC-CHG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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