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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000623
Receipt No. R000000755
Scientific Title Clinical examination about immunoadsorption therapy for dilated cardiomyopathy
Date of disclosure of the study information 2007/03/01
Last modified on 2012/11/29

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Basic information
Public title Clinical examination about immunoadsorption therapy for dilated cardiomyopathy
Acronym Immunoadsorption examination for DCM
Scientific Title Clinical examination about immunoadsorption therapy for dilated cardiomyopathy
Scientific Title:Acronym Immunoadsorption examination for DCM
Region
Japan

Condition
Condition dilated cardiomyopathy
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects and safety of immunoadsorption therapy in severe heart failure patients with dilated cardiomyopathy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes 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).
Key secondary outcomes Presence of side effect during 3-5 immunoadsorption therapies (10-20days).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria NYHA 3 or 4, Left ventricular ejection fraction less than 30%, more than 6 months of standard medical treatments.
Key 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.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Akaishi
Organization Kitasato Institute Hospital
Division name Department of Cardiology
Zip code
Address 5-9-1 Shirokane Minato-ku, Tokyo
TEL 03-3444-6161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akiyasu Baba
Organization Kitasato Institute Hospital
Division name Department of Cardiology
Zip code
Address 5-9-1 Shirokane Minato-ku, Tokyo
TEL 03-3444-6161
Homepage URL http://www.kitasato.or.jp/hokken-hp
Email web-hospital@kitasato.or.jp

Sponsor
Institute Department of Cardiology, Kitasato Institute Hospital
Institute
Department

Funding Source
Organization Department of Cardiology, Kitasato Institute Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 03 Month 01 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/circj/74/7/74_CJ-09-0748/_pdf
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/circj/74/7/74_CJ-09-0748/_pdf
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2009 Year 11 Month 18 Day
Date of closure to data entry
2009 Year 11 Month 18 Day
Date trial data considered complete
2009 Year 11 Month 18 Day
Date analysis concluded
2009 Year 11 Month 18 Day

Other
Other related information

Management information
Registered date
2007 Year 02 Month 28 Day
Last modified on
2012 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000755

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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