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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 : 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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020939
Enrollment
140
Registered
2016-02-09
Start date
2016-02-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia with heart failure

Interventions

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

Sponsors

Dokkyo Medical University Department of Cardiovascular Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Rate of change in NT-proBNP from baseline to the 24th week

Countries

Japan

Contacts

Public ContactHiroki Takayama

Soiken Inc. Clinical Study Support Division

takayama@soiken.com03-3295-1350

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026