UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009434 |
|---|---|
| Receipt number | R000011088 |
| Scientific Title | Clinical examination about immunoadsorption therapy for anti-myocardial autoantibodies-positive severe heart failure under the standard treatment |
| Date of disclosure of the study information | 2012/11/29 |
| Last modified on | 2016/09/21 17:51:45 |
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Basic information
Public title
Clinical examination about immunoadsorption therapy for anti-myocardial autoantibodies-positive severe heart failure under the standard treatment
Acronym
Immunoadsorption examination for anti-myocardial autoantibodies
Scientific Title
Clinical examination about immunoadsorption therapy for anti-myocardial autoantibodies-positive severe heart failure under the standard treatment
Scientific Title:Acronym
Immunoadsorption examination for anti-myocardial autoantibodies
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 anti-myocardial autoantibodies-positive severe heart failure patients such as dilated cardiomyopathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Left ventricular ejection fraction
Key secondary outcomes
Body weight, 6 minutes walking test, cardio-thoracic ratio, echocardiographic parameters, and plasma ANP,BNP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Unconditional Treatment Group: Three months after the first course immunoadsorption (3 times), if left ventricular ejection fraction is improved by <5%, additional 5 times immunoadsorption is unconditionally performed as the second course.
Interventions/Control_2
Randomized Treatment Group: Three months after the first course immunoadsorption (3 times), if left ventricular ejection fraction is improved by >5%, additional 5 times immunoadsorption is performed as the second course with the randomization (1:1).
Interventions/Control_3
Randomized No Treatment Group: Three months after the first course immunoadsorption (3 times), if left ventricular ejection fraction is improved by >5%, additional immunoadsorption is stopped with the randomization (1:1).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
NYHA 2 or 3 or 4, Left ventricular ejection fraction <40%, more than 6 months of standard medical treatments. Cardio-depressant anti-myocardial autoantibody: positive.
Key exclusion criteria
Patients on an ACE inhibitor which cannot be switched to an ARB, Acute myocarditis, Active infectious disease, Neoplasm, Excess alcoholic damages on liver or heart, Pregnancy.
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiyasu Baba |
Organization
Kitasato Institute
Division name
Department of Cardiology, Kitasato Institute Hospital
Zip code
Address
5-9-1 Shirokane Minato-ku, Tokyo, 108-8642 Japan
TEL
03-3444-6161
ababa68@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiyasu Baba |
Organization
Kitasato Institute
Division name
Department of Cardiology, Kitasato Institute Hospital
Zip code
Address
5-9-1 Shirokane Minato-ku, Tokyo, 108-8642 Japan
TEL
03-3444-6161
Homepage URL
chiken@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato Institute Hospital, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
学校法人北里研究所・北里大学・北里研究所病院循環器内科（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2012 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 29 | Day |
Last modified on
| 2016 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011088
