Ischemic cardiomyopathy
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Ischemic cardiomyopathy 2) NYHA class III, IV 3) Patients who can not expect symptomatic improvement with standard treatment for target disease. To be recognized by the third party committee with experts. 4) Ejection fraction <= 35%
Exclusion criteria
Exclusion criteria: 1) Autoimmune disease 2) Allergic or hypersensitive to the immunosuppressant 3) Severe infection 4) Persistent shock due to worsening heart failure 5) Irreversible organ failure other than heart 6) Maignancy 7) Pregnancy 8) Alcoholic or drug addiction in recent six months 9) Allergies or hypersensitivity to animals from which raw materials used 10) Severe pulmonary hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with improved LVEF compared with preoperative at 26 weeks after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Number of responders at 26 and 52 weeks after transplantation 2) Evaluation of the following changes before 26 and 52 weeks after transplantation (1) LVEF (2) Left ventricular remodeling (3) Severity of heart failure (4) Rejections (5) Others | — |
Contacts
Osaka university hospital