Severe heart failure due to chronic ischemic heart disease
Conditions
Interventions
Sponsors
Terumo Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who are chronic ischemic heart disease. (2) Patients who are classified as NYHA class 3 or 4. (3) Patients who are heart failure even under maximal oral medication including digitalis, diuretic, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, aldosterone antagonist and oral inotropic agents. (4) Patients of 20 years or more at the time of obtaining informed consent. (5) Patients who are concerned with worsening heart failure even though standard treatments such as CABG, mitral valvuloplasty, surgical ventricular restoration, CRT, and PCI were conducted over 3 months ago . (6) Patients who have less than LVEF 35 percent determined by echocardiography at rest. (7) Patients who provide first-person informed consent. (8) Patients who are expected to be resident in Japan about two years after obtaining informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients who have signs of skeletal muscle disease. (2) Patients under treatment with thyroid hormone. (3) Patients with infectious disease(HIV,HBV,HCV,HTLV1). (4) Patients in shock due to worsening heart failure. (5) Patients with intercurrent cardiovascular abnormalities that are judged to affect the clinical trial by the investigator or the sub investigators. (6) Patients with irreversible organ failure other than the heart. (7) Patients with a malignant tumor. (8) Patients who are pregnant or possibly pregnant. (9) Patients who cannot receive a blood transfusion. (10) Patients with a history of drug addiction or alcohol addiction within 6 months before obtaining informed consent.(11) Patients with hypersensitivity to antibiotics or animal origin materials such as fetal bovine serum. (12) Patients with severe pulmonary hypertension. (13) Patients with a history of other clinical study within 6 months. (14) Patients who are judged to be inappropriate for the study by the investigator or the sub investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in LVEF at 26 weeks after the transplantation. | — |
Countries
Japan
Outcome results
None listed