heart failure, bone marrow cells
Conditions
Interventions
1. After written informed consent has been obtained, quality of life and exercise capacity will be investigated. In addition myocardial perfusion, viability and sympatic innervation and function will
3. Patients will be randomised to receive bone marrow cells or placebo. In all patients NOGA mapping will be performed with subsequent intramyocardial injection of autologous bone marrow-derived monon
4. Quality of life and exercise capacity will be reassessed at 3 and 6 monhts follow-up. In addition, changes in myocardial function perfusion, viability and sympatic innervation and function will be
Sponsors
Department of Cardiology Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ischemic heart failure NYHA class 2, 3 or 4 despite optimal pharmacological and non- pharmacological therapy; 2. No candidate for (repeat) surgery (revascularization, valve repair or ventricular reconstruction); 3. No candidate for (repeat) percutaneous revascularization; 4. Optimal resynchronization therapy or no candidate for resynchronization therapy; 5. Male or female, > 18 years and < 75 years old; 6. Life expectancy more than 6 months; 7. Able to perform an exercise tolerance test prior to therapy; 8. Able and willing to undergo all the tests used in this protocol including the traveling involved; 9. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence of cancer (except low grade and fully resolved non-melanoma skin malignancy); 2. Concurrent participation in a study using an experimental drug or an experimental procedure within 2 months before randomization; 3. Other severe concurrent illnesses (including active infection, aortic stenosis defined as aortic valve area below 1.0cm2, severe renal insufficiency defined as a GFR <30 mL/min/1.73m2); 4. Bleeding diathesis, HIV infection or pregnancy; 5. Any other condition that, in the opinion of the investigator, could pose a significant threat to the subject if the investigational therapy will be initiated; 6. Inability to undergo cardiac catheterization or nuclear testing; 7. Inability to follow the protocol and comply with follow-up requirements; 8. Candidate for surgery (revascularization, valve repair or ventricular reconstruction), resynchronization therapy or percutaneous revascularization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in left ventricular ejection fraction at 3 monhts follow-up relative to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical end points: 1. New York Heart Association grading of heart failure; 2. Quality of life; 3. Exercise capacity; 4. Canadian cardiovascular society score. Functional end points: 5. Regional myocardial perfusion at 3 monhts follow-up; 6. Viability and sympatic innervation at 3 months follow-up. Safety: 7. Occurence of ahrrythmias; 8. Pericardial effusion > 5 mm (echo); 9. Myocardial damage; 10. Severe inflammation. | — |
Contacts
Public ContactD.E. Atsma
Leiden University Medical Center Department of Cardiology Postbus 9600
Outcome results
None listed