UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA : A (Prospective) Randomized Controlled Clinical Trial of Topiroxostat and Alloprinol
Acronym	The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA (Excite-UA study)
Scientific Title	The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA : A (Prospective) Randomized Controlled Clinical Trial of Topiroxostat and Alloprinol
Scientific Title:Acronym	The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA (Excite-UA study)
Region	Japan

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

Objectives
Narrative objectives1	To compare the effects of topiroxostat and allopurinol on heart and endothelial functioning among patients with hyperuricemia complicated with heart heart failure
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of change in NT-proBNP from baseline to the 24th week
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: administering topiroxostat with minimum amount of 20 mg twice a day (after breakfast), and gradually increase the amount every four weeks aiming for blood uric acid level 6.0 mg/dL or lower Dosage per day can be increased up to 160 mg/day, and keep the dosage during the study The dosage is decreased one level (20 mg) when uric acid level is at 20 mg/dL or lower
Interventions/Control_2	Group B: administering allopurinol, starting with 100 mg once a day as a minimum dose (after breakfast) Dosage is not increased when eGFR is below 50 ml/min/1.73 square meters (or CCr 50 ml/min) Dosage is increased every 4 weeks, from 100 mg per day to 100 mg twice a day, and 100 mg three times a day aiming for blood uric acid 6.0 mg/dL, when eGFR is 50 ml/min/1.73 square meters (or CCr 50 ml/min) or above The dosage is decreased one level (20 mg) when uric acid level is at 20 mg/dL or lower
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who meet all of the following criteria are included in this study. 1. Patients with hyperuricemia (untreated with uric acid level 7.0 mg/dl or above, or currently on medication) with a history of heart failure (however BNP is 40 pg/ml or above according to the Japan Heart Failure Society) 2. Not using any medication for hyperuricemia for more than four weeks before the study 3. Being able to provide written informed consent 4. 20 years of age or older, and younger than 85 years of age at time of providing their written informed consent
Key exclusion criteria	Patients who fall into any of the following criteria are excluded from participating in the study. 1.Have a history of hypersensitivity to the test drug 2.Currently on medication of mercaptopurine hydrate or azathioprine 3.Currently have a severe liver failure (AST or ALT level is doubled from the standard values provided by each hospital/clinic) 4.Complicated with chronic liver disease, malignant tumor, active infection, or inflammatory disease 5.Currently have gout arthritis or the disease is cured for less than two weeks 6.Currently have nephrolithiasis or on treatment 7.eGFR is below 30 ml/min/1.73 square meters (CCr 30ml/min) 8.Currently have acute heart failure 9.After acute exacerbation improvement in chronic heart failure is less than two weeks 10. Currently pregnant or possibly conceived a child, or brest feeding 11.Other conditions that physicians judge to be inappropriate to be in the study
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Teruo Middle name Last name Inoue
Organization	Dokkyo Medical University
Division name	Department of Cardiovascular Medicine
Zip code	321-0207
Address	880 Kitakobayashi Mibu-cho Simotsuga-gun, Tochigi Japan
TEL	0282-87-2146
Email	inouet@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support Division
Zip code	101-0052
Address	NBF Ogawamachi Building 4F, Kanda Ogawamachi 1-3-1, Chiyoda-ku, Tokyo 101-0052
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Dokkyo Medical University Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Sanwa Kagaku Kenkyusho Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical Review Board of Dokkyo Medical University School of Medicine
Address	880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
Tel	0282-87-2275
Email	r-kenkyu@dokkyomed.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	2016 Year 02 Month 09 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	2015 Year 11 Month 30 Day
Date of IRB	2015 Year 10 Month 13 Day
Anticipated trial start date	2016 Year 02 Month 10 Day
Last follow-up date	2018 Year 10 Month 15 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 02 Month 28 Day
Date analysis concluded	2019 Year 05 Month 20 Day

Other
Other related information

Management information
Registered date	2016 Year 02 Month 08 Day
Last modified on	2020 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024159