Hyperuricemic CHF patients with preserved ejection fraction
Conditions
Interventions
Methods of administering topiroxostat <
Increase amount of topiroxostat>
Orally take topiroxostat twice a day
morning and night. Aiming serum uric acid level 6.0mg/dL or lower, the amount of the study drug has to be increased in order from (1) to (2) and to (3) as stated below. When uric acid level 6.0mg/dL o
Decrease amount of topiroxostat>
After initiating topiroxostat, if serum uric acid went below 3.0mg/dL, the dosage before current one must be prescribed.
Sponsors
Nippon Medical School Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. Patients who are at age of 20 or older and younger than age of 80 at the time of consenting 2. Patients with gout or hyperuricemia at the time of consenting 3. Patients who have not taken medication for hyperuricemia within 12 weeks before consenting 4. Patients with CHF classified as NYHA II to IV and LVEF is 50% or more 5. Patients with stable heart failure (NYHA class is stable, and medication for heart function has stayed the same within 4 weeks before consenting) 6. Patients who are capable of giving their consent in a written form
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients who have a medical history of hypersensitivity to topiroxostat, febuxostat, or allopurinol (2) Patients who are currently using mercaptopurine hydrate, or planning to use it (3) Patients who are currently using azathioprine, or planning to use it (4) Patients who are going to have coronary artery bypass or revascularization within 6 months (5) Patients with malignancy (except those who are completely cured)* (6) Patients whose ALT and AST are doubled or more from the standard levels of the institution (7) Patients with chronic hepatitis B or C, and classified active (8) Patients complicated with hepatic cirrhosis* (9) Patients with eGFR 30mL/min/1.73m2 or below and show renal function impairment (10) Patients with other conditions that the attending physician thinks inappropriate to participate in this study * It is based on the decision of their physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change of BNP from baseline to the 24th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Values and changes of the following items (1) to (6) at each observation point (1) Uric acid evaluation (serum uric acid level, XOR activity, hypoxanthine, xanthine) (2) Heart function (BNP, NT-proBNP, troponin T, hs-CRP, CTR, LVEF [the Teichholz method, and the modified Simpson method], LVEDV, LVESV, LVDd, LVDs, LVMI, E/E', E/A, DcT, left atrial dimension (LAD), LA area, TAPSE, TRPG) (3) Vascular endothelium function (using Endo-PAT) (4) Oxidative stress marker, vascular endothelium marker, etc. (ADMA, ICAM-I, VEGF, IL-6, MMP-2, MMP-9, MDA-LDL, dROMs, urinary 8-OHdG) (5) Renal function (BUN, Cr, e-GFR, cystatin C, urinary L-FABP) (6) General blood test items, body weight, BMI, blood pressure, pulse | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed