ischaemic heart failure
Conditions
Interventions
Treatment group:
NOGA mapping guided injection of 100 million allogeneic adipose derived stem
cells (CSCC_ASC) with MYOSTAR injection catheter
Control group:
NOGA mapping guided injection of placeb
Sponsors
Rigshospitalet Copenhagen University Hospital, Capital Region of Denmark
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. 30 to 80 years of age 2. Signed informed consent 3. Chronic stable ischemic heart disease 4. Symptomatic Heart failure (NYHA II-III) 5. LVEF 300 pg/ml (> 35 pmol/L) 7. Maximal tolerable heart failure medication 8. Medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics accepted. 9. No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) 10. Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis 11. Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device (CRTD) and 1 month after an ICD unit
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Heart Failure (NYHA I or IV) 2. Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion. Constant elevated troponin due to renal failure, heart failure etc. do not exclude the patient. 3. Other revascularisation treatment within four months of treatment 4. If clinically indicated the patient should have a coronary angiography before inclusion 5. Moderate to severe aortic stenosis (valve area 14 109/L) or thrombocytopenia (thrombocytes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up between CSCC_ASC and placebo treated measured by echocardiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are safety evaluated by development of allogeneic antibodies and laboratory safety measurements 1, 3, 6 and 12 months after treatment and changes in left ventricular ejection fraction (LVEF), end-diastolic volume and myocardial mass at 6 months follow-up. The changes in left ventricle function will be measured by echocardiography (ECHO) or computed tomography (CT). LVESV is a widely used measure of the functional status of the left ventricle and is superior to LVEF for prediction of survival in patients with LVEF below 50%. Other secondary endpoints are changes in NYHA, CCS, Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, 6 min walking test, additional echocardiographic measures (Global strain %, left atrium volume, e*, s*) and NT-pro-BNP. In addition, safety of allogeneic CSCC_ASCs with respect to incidence and severity of serious adverse events and suspected unrelated serious adverse events will be evaluated at 12 months follow-up. A combined endpoint of 1. death, hospitalization for worsening heart failure including inserting of a bi-ventricular pacemaker, hospitalization because of ventricular tachycardia or fibrillation 1, 2 and 3 years after treatment 2. death, hospitalization for any cardiovascular reason, hospitalization for worsening heart failure including inserting of a bi-ventricular pacemaker, hospitalization because of ventricular tachycardia or fibrillation 1, 2 and 3 years after treatment. | — |
Countries
Netherlands
Outcome results
None listed