Clinical examination about immunoadsorption therapy for dilated cardiomyopathy

UMIN ID: UMIN000000623

Registered date:01/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: dilated cardiomyopathy
• Date of first enrollment: 2007/03/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): During 10-20 days for study period, 3-5 immunoadsorption therapies will be performed by IMMUSORBA TR (AsahiKasei Medical CO.), which plasma throughput is 2-2.5 liters, three hours per once.

Outcome(s)

• Primary Outcome: Changes of body weight, 6 minutes walking test, cardio-thoracic ratio, echocardiographic parameters, left ventricular ejection fraction, and plasma BNP level after 3-5 immunoadsorption therapies (10-20days).
• Secondary Outcome: Presence of side effect during 3-5 immunoadsorption therapies (10-20days).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: On ACE inhibitors, With known heart basal diseases, Acute myocarditis, Active infectious disease (including viral hepatitis), Neoplasm, Excess alcoholic damages on liver or heart, Pregnancy.

Related Information

• Primary Sponsor: Department of Cardiology, Kitasato Institute Hospital
• Source(s) of Monetary Support: Department of Cardiology, Kitasato Institute Hospital