UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009434
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email chiken@kitasato-u.ac.jp

Sponsor
Institute Kitasato Institute Hospital, Kitasato University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.