Clinical Study for the Immunoadsorption Therapy of Dilated Cardiomyopathy using AMT-0902-1: Prospective, Multicenter, Randomized, Self- and Parallel Group- Comparative Study to Evaluate the Efficacy and Safety.
- Conditions
- Dilated cardiomyopathy(DCM)
- Registration Number
- JPRN-UMIN000003106
- Lead Sponsor
- ASAHIKASEI KURAREY MEDICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method