Unique ID issued by UMIN | UMIN000020939 |
---|---|
Receipt number | R000024159 |
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 |
Date of disclosure of the study information | 2016/02/09 |
Last modified on | 2020/03/12 09:47:13 |
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
The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA (Excite-UA study)
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
The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA (Excite-UA study)
Japan |
Hyperuricemia with heart failure
Cardiology |
Others
NO
To compare the effects of topiroxostat and allopurinol on heart and endothelial functioning among patients with hyperuricemia complicated with heart heart failure
Safety
Rate of change in NT-proBNP from baseline to the 24th week
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
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
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
20 | years-old | <= |
85 | years-old | > |
Male and Female
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
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
140
1st name | Teruo |
Middle name | |
Last name | Inoue |
Dokkyo Medical University
Department of Cardiovascular Medicine
321-0207
880 Kitakobayashi Mibu-cho Simotsuga-gun, Tochigi Japan
0282-87-2146
inouet@dokkyomed.ac.jp
1st name | Hiroki |
Middle name | |
Last name | Takayama |
Soiken Inc.
Clinical Study Support Division
101-0052
NBF Ogawamachi Building 4F, Kanda Ogawamachi 1-3-1, Chiyoda-ku, Tokyo 101-0052
03-3295-1350
takayama@soiken.com
Dokkyo Medical University
Department of Cardiovascular Medicine
Sanwa Kagaku Kenkyusho Co., Ltd.
Profit organization
Ethical Review Board of Dokkyo Medical University School of Medicine
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
0282-87-2275
r-kenkyu@dokkyomed.ac.jp
NO
2016 | Year | 02 | Month | 09 | Day |
Unpublished
Completed
2015 | Year | 11 | Month | 30 | Day |
2015 | Year | 10 | Month | 13 | Day |
2016 | Year | 02 | Month | 10 | Day |
2018 | Year | 10 | Month | 15 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 05 | Month | 20 | Day |
2016 | Year | 02 | Month | 08 | Day |
2020 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024159