hyperuricemia complicated by hypertension
Conditions
Interventions
Intervention content Dotinurad will be administered starting at 0.5 mg once daily with a maintenance dose of 2 mg for a maximum of 4 mg for 24 weeks. If the patient is using an antihyperuricemic at th
Sponsors
Node Koichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 20 years or older at the time when consent was obtained (regardless of gender) 2) Patients with hyperuricemia and a serum uric acid level of greater than 7.0 mg/dL 3) Patients with hypertension, who meet the definition of JSH2019, without change in the pharmacological and/or non-pharmacological treatment for hypertension within 4 weeks prior to eligibility assessment 4) Patients who provided their written consent to participate in this research
Exclusion criteria
Exclusion criteria: 1) Patients whose inflammation did not subside after acute gouty arthritis 2) Patients who are currently suffering from urolithiasis 3) Patients with known secondary hyperuricemia who are suffering from any of the following diseases: Lesch-Nyhan syndrome, phosphoribosyl pyrophosphate synthetase superactivity, congenital myogenic hyperuricemia, hematopoietic organ tumor (acute leukemia, malignant lymphoma, myeloproliferative disorder, myelodysplastic syndrome), solid tumor (breast cancer, seminoma, sarcoma, Wilms tumor, small cell lung cancer), non-neoplastic disease (psoriasis vulgaris, secondary polycythemia, hemolytic anemia), tumor lysis syndrome, rhabdomyolysis, hypothyroidism, polycystic kidney, lead poisoning/lead nephropathy, Down's syndrome, familial juvenile gouty nephropathy, hyperlactacidemia, or glycogen storage disease type I 4) Patients with hypertensive emergency and urgency 5) Patients with complications from active malignancy 6) Patients with serious hepatic dysfunction 7) Patients with severe renal dysfunction with oliguria or anuria 8) Patients who are pregnant, suspected to be pregnant, or breastfeeding 9) Patients with a history of hypersensitivity to the ingredients contained in dotinurad preparations 10) Patients who the principal investigator or subinvestigator considers not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in serum uric acid levels from Week 0 until Week 24 after the administration of dotinurad | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes and rates of change in serum uric acid levels at Weeks 4, 8, 12, and 24 after the administration of dotinurad (except for evaluations related to the primary outcomes) 2) Percentage of patients who reached a serum uric acid level of 6.0 mg/dL or below at Weeks 4, 8, 12, and 24 after the administration of dotinurad 3) Changes and rates of change in CAVI, AI, %MAP at Week 24 after the administration of dotinurad 4) Changes and rates of change in blood biomarker (CRP, GDF-15, NT-proBNP, hs-TnT, IL-6, and d-ROMs) at Week 24 after the administration of dotinurad 5) Changes and rates of change in systolic/diastolic blood pressure, pulse pressure at Weeks 4, 8, 12, and 24 after the administration of dotinurad 6) Changes and rates of change in the laboratory test levels, UACR at Weeks 12 and 24 after the administration of dotinurad (except for UACR at Week 12) 7) Changes and rates of change in RHI, AI, HRV, SDNN, LF/HF at Week 24 after the administration of dotinurad | — |
Contacts
Public ContactAtsushi Tanaka
Saga University Hospital
Outcome results
None listed