UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Reduced Form of Coenzyme Q10 (ubiquinol) on Heart Failure and Arrhythmias
Acronym	CoQ10-HF
Scientific Title	Effects of Reduced Form of Coenzyme Q10 (ubiquinol) on Heart Failure and Arrhythmias
Scientific Title:Acronym	CoQ10-HF
Region	Japan

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

Objectives
Narrative objectives1	To elucidate improving effects of reduced form of Coenzyme Q10 (ubiquinol) on congestive heart failure and arrhythmias of the patients with implantation of pacemaker or ICD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Heart filure indices (OptiVol or CorVue), arrhythmias of the implanted device before and 6months after ubiquinol/placebo
Key secondary outcomes	activity time recorded on the implanted device Physical Activity Score Nutrition (CONUT score, GNRI) BNP

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	placebo and conventional therapy 6 months
Interventions/Control_2	Add-on of reduced form Coenzyme Q10 100mg three times a day 6 months
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	patients of congestive heart failure (NYHA II and above) with pacemaker or implantable cardioverter defibrillator implantation, including cardiac resynchronization therapy
Key exclusion criteria	none
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Satoaki Middle name Last name Matoba
Organization	Kyoto Prefectral University of Medicine
Division name	Cardiovascular Medicine
Zip code	602-8566
Address	Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5511
Email	matoba@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Shirayama
Organization	Kyoto Prefectral University of Medicine
Division name	Cardiovascular Medicine
Zip code	602-8566
Address	Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5511
Homepage URL
Email	sirayama@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectral University of Medicine, Division of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectral University of Medicine, Division of Cardiovascular Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

IRB Contact (For public release)
Organization	Clinical Research Review Board
Address	Kamawamachi-Hirokoji, kamigyo-ku, kyoto, Japan
Tel	075-251-5337
Email	rinri@koto.kpu-m.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	京都府立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 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	10
Results	no results because of termination
Results date posted	2019 Year 11 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events	none
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 05 Month 04 Day
Date of IRB	2017 Year 10 Month 10 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 05 Month 04 Day
Last modified on	2019 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029847