Ischemic cardiomyopathy
Conditions
Interventions
After coronary artery bypass grafting, patients will be randomly assigned 1:1 to the investigational product group or placebo group, and the S-005151 or placebo will be administered continuously for 5
D010455
Peptides
Sponsors
Shigeru Miyagawa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who diagnosed with ischemic cardiomyopathy and undergoing coronary artery bypass surgery through open heart surgery 2) LVEF <40% 3) Patients who taking medication for heart failure 4) NYHA class 2,3,4 5) Patients who can obtain written consent from the subject to participate in the clinical trial 6) Patients who can continue to visit the study site for 52 weeks after administering study drug
Exclusion criteria
Exclusion criteria: 1) Patients who concomitant severe cardiovascular abnormalities 2) Patients who irreversible organ failure other than the heart 3) Patients who NYHA class 4 and meet the following Uunder administration high-dose catecholamine Mechanically assisted circulatory support 4) History of active malignancy within 5 years 5) History of breast cancer within 10 years 6) Patients who pregnancy, do not agree to contraception,breastfeeding 7) Patients who cannot receive blood transfusions 8) Severe liver or renal dysfunction 9) Unstable liver disease or biliary tract disease 10) Alcoholism or drug addiction within 6 months before registration 11) Severe psychosis or psychotic symptoms 12) Severe drug allergy 13) Receiving treatment with procoagulants, antifibrinolytic agents, and aprotinin preparations 14) Participating in other clnical trials,within 6 months after participating in other clinical trial 15) Patients who have received Redasemtide treatment in the past 16) Patient deemed unsuitable as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of continuously intravenous administration of redasemtide after coronary artery bypass surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy of continuously intravenous administration of redasemtide within 21 days after coronary artery bypass surgery for ischemic cardiomyopathy will be evaluated on the transition of cardiac function. | — |
Contacts
Public ContactYusuke Misumi
Osaka university hospital
Outcome results
None listed