Dilated cardiomyopathy(DCM)
Conditions
Interventions
Immunoadsorption group: After the examination at the start is completed, 5 sessions of immunoadsorption therapy using AMT-0902-1 will be performed in 2 weeks (first treatment stage). Three months afte
Sponsors
ASAHIKASEI KURAREY MEDICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Idiopathic DCM (diagnosed following the "Guide and Explanation of Diagnosis of Cardiomyopathy) *Exclude Specified myocardial disease (Secondary myocardial disease) below 1) Ischemic myocardial disease 2) Valvular myocardial disease 3) Hypertensive myocardial disease 4) Inflammatory myocardial disease 5) Metabolic myocardial disease 6) Systemic myocardial disease 7) Muscular dystrophy 8) Nervous/Muscular disease 9) Hypersensitivity/Toxic disease 10) Postpartal cardiomyopathy (2) NYHA (New York Heart Association) class III-IV (3) LVEF < 30% measured by RI or LVEF < 35% measured by echocardiography in the past 3 months(12 weeks) (4) Being resistant to standard therapy with ACE inhibitors or ARB, b-blocker and Aldosterone antagonists for heart failure for at least 3 months prior to screening date. (5) 18 years-old or older (6) Male or female patients (7) Inpatients or outpatients
Exclusion criteria
Exclusion criteria: (1) Secondary DCM resulting from other diseases(e.g.hypertrophic or restrictive cardiomypathy) (2)Left ventricular noncompaction (3)Implanted with left ventricular assist device(LVAD) (4)Received Cardiac resynchronization therapy(CRT or CRT-D) in the past 6 months (5) Received Heart transplantation (6) Patients on an ACE inhibitor, which cannot be switched to an ARB (7)Weight <40kg (8)Platelet number <100,000/mm3 (9)Leukocyte number <3,000/mm3 (10)Anemia(hemoglobin <10 g/dL) (11)History of shock during extracorporeal circulation treatments (12) Impaired renal function (serum creatinine level >3 mg/dl) Impaired hepatic function (AST(GOT) or ALT(GPT) >2.5 times the upper limit of normal or >100 IU/L) (13) Being treated for a malignant tumor (14) Pregnant or potentially pregnant women or women who desire to become pregnant during the study period (15) Infected, or suspected to be infected, with HBV, HCV, or HIV (16) Patients who have difficulty understanding the informed consent document (17) Participation in any other clinical study within 26 weeks(182 days) before providing their informed consent (18) Previous treatments for DCM with AMT-0902-1 (19) Considered inappropriate for the clinical study by an investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LVEF change (by RI) within 3 months after the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Comparison of LVEF (by RI) between immunoadsorption group and delay group at 3 months from baseline 2) Comparison of LVEF (by RI) between immunoadsorption group and delay group at 6 months from baseline 3) LVEF by echocardiography, Analysis of the primary outcome and 1) and 2) of secondary outcome 4) Cardiac events up to 12 months 5) Analysis of subgroup (antimyocardial autoantibody, subject demographics) 6) Evaluation of 6-minute walk test, cardiothoracic ratio, cardiopulmonary exercise testing, BNP and ANP 7) Evaluation of NYHA classification and QOL questionnaire (with specific activity scale: SAS) 8) Overall evaluation of echocardiography 9) Evaluation of safety | — |
Countries
Japan
Contacts
Public ContactYoichi Kato
ASAHIKASEI KURAREY MEDICAL CO., LTD. Clinical Development Center
Outcome results
None listed