Chronic Heart Failure Clinical Trial
Official title:
Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy
BACKGROUND. In patients with non-ischemic dilated cardiomyopathy, intracoronary stem cell
transplantation has been shown to improve exercise capacity, reduce ventricular remodelling
and improve 1-year survival. Pre-clinical data demonstrate that stem cell effects on the
diseased heart can be further enhanced by direct intramyocardial delivery route.
AIMS.
1. To evaluate safety and efficacy of intramyocardial stem cell therapy in patients with
non-ischemic dilated cardiomyopathy.
2. To directly compare clinical effects of intracoronary and intramyocardial stem cell
delivery.
METHODS. Of 60 patients with dilated cardiomyopathy, 30 will be randomized to
intramyocardial transplantation of CD34+ cells (Study Group), and 30 will receive
intracoronary stem cell therapy (Control Group). In both groups peripheral blood stem cells
will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be
collected via apheresis and labelled with technetium. In the Study Group electromechanical
mapping will be used to identify viable myocardium and intramyocardial injections in the
target areas will be performed with NOGA catheter. In the Control group patients will
undergo myocardial perfusion scintigraphy and CD34+ cells will be injected intracoronary in
the artery supplying segments of reduced viability. Patients will be followed for 1 year.
Primary endpoints will include changes in left ventricular ejection fraction and left
ventricular dimensions (measured by echocardiography). Secondary endpoints will include
changes in exercise capacity and changes in NT-proBNP values.
HYPOTHESES.
1. At 1 year, intramyocardial stem cell therapy will be associated with improved left
ventricular ejection fraction, reduced left ventricular dimensions, improved exercise
capacity and reduced levels of NT-proBNP.
2. Beneficial effects of intramyocardial stem cell therapy will be superior to those
observed with intracoronary stem cell delivery.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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