Effect of urate LowEring Agent Febuxostat in Chronic Heart Failure patients with hyperuricemia
- Conditions
- Chronic heart failure patients with hyperuricemia
- Registration Number
- JPRN-UMIN000013330
- Lead Sponsor
- EAF-CHF steering committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
(1) Drugs for hyperuricemia, within 2 weeks before confirmation of eligibility. Allopurinol, Benzbromarone, Probenecid, Bucolome, Topiroxostat, Febuxostat (2) Drugs at the time of confirmation of eligibility. Mercaptopurinehydrate, Azathioprine, Vidarabine, Dinanosine (3) Gouty tophus or certain symptom of gouty arthritis within 1 year before eligibility confirmation. (4) Acute myocardial infarction or coronary arterial revascularization within 3 month before eligibility confirmation. (5) Planned cardiac surgery such as coronary arterial valve operation, during participation of this study. (6) Heart failure caused by valvular heart disease or congenital heart disease. (7) Severe hepatic, or renal dysfunction, dialysis or malignancy disqualified from the study by the investigators. Severe hepatic dysfunction is defined as twice the upper limit of baseline AST or ALT. Severe renal dysfunction is defined as eGFR <30/mL/min/1.73m2. eGFR is calculated by formula shown in "CKD diagnostic guideline 2012 by Japanese Society of Nephropathy" eGFR(mL/min/1.73m2)=194*Cr^(-1.094)*Age^(-0.287)(Female *0.739) (8) Febuxostat hypersensitivity. (9) Pregnant, possibly pregnant, brest-feeding, or expecting to conceive. (10)Participated in other clinical study within 6 months before confirmation of eligibility. (11)Considered to be inappropriate for the participation in this study by the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change of BNP from baseline after 24 week treatment
- Secondary Outcome Measures
Name Time Method (1)LVEF and E/e' from baseline after 24 week treatment (2)The occurrences of events from 0 to 24 weeks will be evaluated. The details are decided by event evaluation standards defined before staring this study. According to event evaluation standard, Event Evaluation Committee conducts central review an Investigator's assessment by blind study. 1)Death 2)Cardiovascular event Cardiovascular death Hospitalization due to worsening heart failure Hospitalization due to cardiovascular causes Enforcement of heart failure treatment (3) NYHA functional class from baseline after 4, 8, 12, 16, 20 and 24 weeks (4) Lab data from baseline after 4, 8, 12, 16, 20 and 24 week 1)BNP 2)eGFR 3)Hemoglobin 4)Serum uric acid (5) Adverse events during the study period Adverse events from 0 to 24 weeks will be evaluated.