Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- increase of the ejection fraction of the left ventricle
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Stem Cell therapy
Stem Cell therapy
Intervention: Stem cell (Procedure)
Stem Cell therapy
Stem Cell therapy
Intervention: Filgrastime (G-CSF) (Drug)
Standart therapy
Standart therapy
Intervention: Standart therapy (Drug)
Outcomes
Primary Outcomes
increase of the ejection fraction of the left ventricle
Time Frame: 1 year
Secondary Outcomes
- Death by any cause within 1 year of intervention(1 year)
- Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline(1 year)
- Difference in NYHA functional class at six months and baseline(six months)
- Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months(1 year)
Investigators
Bernardo Rangel Tura
Professor
Ministry of Health, Brazil