UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical examination about immunoadsorption therapy for anti-myocardial autoantibodies-positive severe heart failure under the standard treatment
Title of the study (Brief title)	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	Akiyasu Baba
Organization	Kitasato Institute
Division name	Department of Cardiology, Kitasato Institute Hospital
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	Akiyasu Baba
Organization	Kitasato Institute
Division name	Department of Cardiology, Kitasato Institute Hospital
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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