Dilated Cardiomyopathy
Conditions
Keywords
Dilated Cardiomyopathy, stem cells, Therapeutics, Randomized Controlled Trials
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. Hypothesis: The main hypothesis of this study is that the patients who received the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5% increase in absolute left ventricle ejection fraction in comparison with the control group.
Interventions
DRUGoptimal therapy for cardiaca failure
optimal therapy for cardiaca failure
PROCEDUREcell
stem cell
Sponsors
Financiadora de Estudos e Projetos
Ministry of Health, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| increase of the ejection fraction of the left ventricle | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Percent number of patients that reached an absolute increase of 5% in ejection fraction | 1 year |
| Difference in NYHA functional class | 6 month |
| Death by any cause | 1 year |
| Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline | 1 year |
| Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire | 6 month |
Countries
Brazil
Outcome results
None listed