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Clinical examination about immunoadsorption therapy for dilated cardiomyopathy

Phase 2
Conditions
dilated cardiomyopathy
Registration Number
JPRN-UMIN000000623
Lead Sponsor
Department of Cardiology, Kitasato Institute Hospital
Brief Summary

Background: Cardiodepressant IgG3 autoantibodies (CD-Abs) can be targeted by apheresis. Using blinded measurements of CD-Abs before and after immunoadsorption (IA), the cardiac function of patients who did or did not achieve complete CD-Abs elimination was compared. Methods and Results: Autoantibodies were completely removed from 18 patients with heart failure (New York Heart Assocation class 3 or 4, left ventricular ejection fraction (LVEF) <30%) using a selective IgG3 adsorption column. All patients had anti-beta1-adrenergic and/or M2-muscarinic autoantibodies before IA, and all LVEF were measured on radionuclide ventriculography. CD-Abs were measured before and after IA, and patient status was blinded until all measurements were collected. Treatment was defined as complete when CD-Abs status changed from positive to negative after IA. Other instances were defined as incomplete. Six-min walk test results and brain natriuretic peptide levels improved significantly after IA (P<0.01). The increase in LVEF 3 months after IA was significantly greater after complete treatment in comparison to the incomplete treatment group (19+-8 to 29+-9% vs 18+-9 to 17+-8%, P<0.01). Cardiac insufficiency events were also more frequent in the incomplete treatment group. Conclusions: Complete elimination of CD-Abs with apheresis may be related to improved cardiac function in the treatment of heart failure.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Measures
NameTimeMethod
Presence of side effect during 3-5 immunoadsorption therapies (10-20days).
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