UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the REduced form of COenzyme Q10 Supplementation on endothelial function in chronic heart failure
Acronym	RECOQS
Scientific Title	Effect of the REduced form of COenzyme Q10 Supplementation on endothelial function in chronic heart failure
Scientific Title:Acronym	RECOQS
Region	Japan

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

Objectives
Narrative objectives1	To clarify whether ubiquinol improves endothelial function in chronic heart failure patients or not.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in endothelial function assessed by EndoPAT 2000 between before and after intervention.
Key secondary outcomes	Changes in functional capacity, left ventricular function, oxydative stress marker, inflammation marker, and COQ10 concentration in peripheral blood.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ubiquinol 200mg twice daily, 12 weeks, followed by placebo 12 weeks
Interventions/Control_2	Placebo 12 weeks, followed by Ubiquinol 200mg twice daily, 12 weeks
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Chronic heart failure patients whose left ventricular ejection fraction are less than 40 %.
Key exclusion criteria	Malignancy, severe infection, severe trauma, hemodialysis.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Kimura
Organization	Yokohama City University Medical Center
Division name	Division of Cardiology
Zip code	2320024
Address	4-57 Urafune-cho, Minami-ku, Yokohama
TEL	045-261-5656
Email	c-kimura@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Masaaki Middle name Last name Konishi
Organization	Yokohama City University Medical Center
Division name	Division of Cardiology
Zip code	2320024
Address	4-57 Urafune-cho, Minami-ku, Yokohama
TEL	045-261-5656
Homepage URL
Email	m_koni@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Medical Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama
Tel	045-261-5656
Email	chihirou@yokohama-cu.ac.jp

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	2013 Year 12 Month 17 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	2013 Year 06 Month 01 Day
Date of IRB	2012 Year 11 Month 21 Day
Anticipated trial start date	2013 Year 06 Month 02 Day
Last follow-up date	2014 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 12 Month 17 Day
Last modified on	2019 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014738