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The effect of Dotinunrad to suppress the depression of eGFR for Heart Failure with Hyperuricemia

A Multicenter, Single-Arm, Pre-and Post-Comparative Study of Dotinurad in Preventing eGFR Decline in Patients with Chronic Heart Failure Complicated by Hyperuricemia - Dotinurad-HF

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041250020
Enrollment
75
Registered
2025-04-30
Start date
2025-05-30
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

Heart Failure with Hyperuricemia Dotinurad, Heart Failure, Hyperuricemia, eGFR

Interventions

Administer one tablet of the drug Dochinurad 0.5 mg once daily after breakfast. In the 4th week, increase the dosage to 1.0 mg once daily after breakfast. In the 8th week, further increase the dosage

Sponsors

Mizoguchi Tatsuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) At least 18 years old at the time of obtaining consent (2) Diagnosed hyperuricemia with a serum uric acid level (sUA) greater than 7.0 mg/dL (3) eGFR greater than 30 mL/min/1.73m2 and less than 60 mL/min/1.73m2 (4) Verifiable eGFR values measured in the year (plus minus 2 months) before the date of enrollment (5) A confirmed diagnosis of symptomatic chronic heart failure at the time of inclusion, meeting all of the following criteria (a) NT-proBNP greater than 125 pg/mL or BNP greater than 35 pg/mL (b)Typical symptoms and signs of heart failure for at least 6 weeks before enrollment (c)If you are using sodium-glucose co-transporter 2 (SGLT2) inhibitors, they should have been used for at least 6 months before obtaining consent; if using sacubitril/valsartan, it should have been used for at least 4 weeks before receiving permission, and at a stable dose (6) Patients who can obtain written consent based on the free will of the research subject

Exclusion criteria

Exclusion criteria: (1)Patients with active gout attacks (2)Patients with AST or ALT > 100 IU/L (3)Patients with a diagnosis of secondary hyperuricemia (4)Patients with a history of hypersensitivity to dotinurad (5)Patients with a diagnosis of urinary tract stones (6) Pregnant or breastfeeding patients for whom switching to formula is difficult. (7)Other patients deemed by the principal investigator/associate investigator to be ineligible for participation in the study

Design outcomes

Primary

MeasureTime frame
The change of eGFR slope (mL/min/1.73m2/year) before and after Dotinurad administration

Secondary

MeasureTime frame
The change of NT-proBNP before and after Dotinurad administration The change of 6 minutes walk distances before and after Dotinurad administration The change of KCCQ-QS before and after Dotinurad administration The change of the parameters of echocardiography such as left ventricular ejection fraction, left ventricular outflow tract verocity time integral and trans mitral flow before and after Dotinurad administration

Contacts

Public ContactTatsuya Mizoguchi

Nagoya City University Hospital

tatsurushi.mizo@gmail.com+81-52-851-5511

Outcome results

None listed

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