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Injection of Autologous Bone Marrow Cells into Damaged Myocardium of No-option Patients with Ischemic Heart Failure, a randomized placebo-controlled trial.


- candidate number8459
- NTR NumberNTR2516
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-sep-2010
- Secondary IDsP10.081 / NL21184.000.09 ; CME / CCMO
- Public TitleInjection of Autologous Bone Marrow Cells into Damaged Myocardium of No-option Patients with Ischemic Heart Failure, a randomized placebo-controlled trial.
- Scientific TitleInjection of Autologous Bone Marrow Cells into Damaged Myocardium of No-option Patients with Ischemic Heart Failure, a randomized placebo-controlled trial.
- ACRONYM
- hypothesisThe aim of this study is to determine the safety and efficacy of intramyocardial injection of autologous bone marrow cells in no-option patients with severe ischemic heart failure.
- Healt Condition(s) or Problem(s) studiedHeart failure, Bone marrow cells
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-apr-2010
- planned closingdate31-dec-2011
- Target number of participants64
- Interventions1. 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 be documented;
2. Bone marrow will be aspired from the iliac crest under local or general anesthesia;
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 mononuclear cells or placebo;
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 evaluated at 3 months follow-up.
- Primary outcomeThe change in left ventricular ejection fraction at 3 monhts follow-up relative to baseline.
- Secondary outcomeClinical 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.
- TimepointsAt 3 and 6 months follow-up.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. D.E. Atsma
- CONTACT for SCIENTIFIC QUERIESDr. D.E. Atsma
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Cardiology
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD16-sep-2010 - 8-okt-2010


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