UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000623 |
|---|---|
| Receipt number | 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 19:00:49 |
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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
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
web-hospital@kitasato.or.jp
Sponsor or person
Institute
Department of Cardiology, Kitasato Institute Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000755
