UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of a heart failure treatment using a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zinc
Title of the study (Brief title)	Study of a heart failure treatment using a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zinc
Region	Japan

Condition
Condition	heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the improvement of symptoms and QOL with a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zinc in patients with intractable heart failure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.BNP 2.QOL (6-min walk test, EQ-5D) 3.LVEF by echocardiography
Key secondary outcomes

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	Food
Interventions/Control_1	coenzyme Q10
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	Outpatients with chronic heart failure (including DCM and OMI) who meet the following conditions: (1) LVEF < 40% (2) BNP level > 200 pg/mL (3) Plasma coenzyme Q10 concentrations < 950 ng/mL (4) Age >= 20 years (5) Patients who adequately understand the objectives and details of this study, and give a written informed consent
Key exclusion criteria	(1)Patients who meet the following criteria are excluded: those who have not completely recovered from a malignancy; with severe infection; suspected of having a pulmonary disease (including COPD) on a chest radiogram; who are on dialysis; and others who are found unacceptable at the discretion of the physician (2)Patients who have taken drugs or supplements including coenzyme Q10, astaxanthin, and citrulline within the last 2 months
Target sample size	50

Research contact person
Name of lead principal investigator	Masami Sakurada
Organization	Tokorozawa Heart Center, Medical Corporation Ouyuukai
Division name	Cardiovascular desease center
Address	2-61-11, Kamiarai Tokorozawa Saitama 359-1142
TEL	04-2940-8611
Email	masami-saku@mh.point.ne.jp

Public contact
Name of contact person	satomi kohata
Organization	A2 Healthcare Corporation
Division name	Clinical Research Department
Address	Sumitomo Fudosan Bldg,1-4-1,Koishikawa,Bunkyo-ku,Tokyo
TEL	03-3830-1075
Homepage URL
Email	kohata-s@a2healthcare.com

Sponsor
Institute	Tokorozawa Heart Center, Medical Corporation Ouyuukai
Institute
Department

Funding Source
Organization	Your Health Care Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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	1）所沢ハートセンター　 2）三重ハートセンター　 3）草津ハートセンター　 4）豊橋ハートセンター 5）京都桂病院　心臓血管センター　 6）帝京大学医学部附属病院　循環器内科　 7）上尾中央総合病院　心臓血管センター

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 31 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 05 Month 31 Day
Date trial data considered complete	2017 Year 10 Month 30 Day
Date analysis concluded	2017 Year 11 Month 30 Day

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

Management information
Registered date	2015 Year 12 Month 15 Day
Last modified on	2018 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022720