Ischemic heart disease and heart failure MedDRA version: 18.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849
Conditions
Sponsors
Department of Cardiology, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. 30 to 80 years of age 2. Signed informed consent 3. Chronic stable ischemic heart disease 4. Heart failure (NYHA II-III) 5. LVEF =45% 6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm 7. Maximal tolerable heart failure medication 8. Medication unchanged two months prior to inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 79
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 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 < 50 109/L) 8. Anticoagulation treatment that cannot be paused during cell injections 9. Patients with reduced immune response 10. History with malignant disease within five years of inclusion or suspected malignity – except treated skin cancer other than melanoma 11. Pregnant women 12. Other experimental treatment within four weeks of baseline tests 13. Participation in another intervention trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To perform at clinical double-blind placebo-controlled CSCC_ASC multicentre study in heart failure patients to investigate the regenerative capacity of the CSCC_ASC treatment.;Secondary Objective: Improvement in cardiac function and clinical symptoms;Primary end point(s): The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up between CSCC_ASC treatment and placebo patients;Timepoint(s) of evaluation of this end point: 6 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are safety evaluated by development of allogeneic antibodies and laboratory safety measurements 1 and 6 months after treatment and changes in left ventricular ejection fraction (LVEF), end-diastolic volume and myocardial mass at 6 months followup. The changes in left ventricle function will be measured by echocardiography (ECHO) or computed tomography (CT). Other secondary endpoints are changes in NYHA, CCS, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6 min walking test 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 followup. 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 and increased heart failure medical treatment 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 and increased heart failure medical treatment 1, 2 and 3 years after treatment.;Timepoint(s) of evaluation of this end point: 1 and 6 months after treatment and 1, 2 and 3 years | — |
Countries
Austria, Denmark, Germany, Netherlands, Poland, Slovenia
Contacts
Public ContactJens Kastrup
Department of Cardiology, 2014, Rigshospitalet
Outcome results
None listed