Chronic Heart Failure Clinical Trial
— NOGA-DCMOfficial title:
Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy
Verified date | April 2015 |
Source | University Medical Centre Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | Slovenia: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Established dg. of dilated CMP (defined according to ESC position statement - absence of any stenotic lesions on coronary angiography, no congenital heart disease, no primary valve disease on echocardiography, and no history of hypertension or alcohol abuse1) - left ventricular ejection fraction < 30% - NYHA functional class III or IV for at least 3 months before referral - Optimal medical management for at least 6 months Exclusion Criteria: - Left ventricular aneurysm or thrombus - Hematologic disease - Multiorgan failure - Active malignancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Slovenia | UMC Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana | Stanford University, The Methodist Hospital System |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in left ventricular ejection fraction and dimensions | Standard 2D and Doppler echocardiography will be performed at baseline, and repeated at 1 month, 3 months, 6 months and 1 year after the procedure. Left ventricular ejection fraction will be measured using Simpson's method and left ventricular end-systolic and end-diastolic dimensions will be measured according to standard echocardiography protocol. | 1 year | No |
Secondary | Changes in exercise capacity | Exercise capacity will be evaluated with 6-minute walk test at baseline, and again at 1,3,6 and 12 months after the procedure. | 1 year | Yes |
Secondary | Change in NT-proBNP levels | Plasma levels of NT-proBNP will be measured at baseline, and again at 1, 3, 6 and 12 months after the procedure. | 1 year | Yes |
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