Chronic heart failure patients with hyperuricemia
Conditions
Sponsors
Department of Cardiology Osaka Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Male or female outpatients over 20 years old at time the subjects sign the Informed Consent Form (ICF). (2)Serum uric acid level >7.0 mg/dL and <=10.0 mg/dL (3)CHF, NYHA functional class II and III (4)Serum BNP is >= 100 pg/mL or NT-proBNP >= 400 pg/mL (Use measured value at each site for confirmation of eligibility) (5)Systolic dysfunction, LVEF < 40% (Echocardiogram taken within 8 weeks can be used as confirmation of eligibility. However, echocardiogram at examination on admission cannot be used.) (6)History of hospitalization due to worsening CHF within 2 years prior to confirmation of eligibility. Admission only for work up is excluded. (7) Stable for 4 weeks prior to eligibility test, without changes in NYHA functional class and dose of drugs for heart failure such as angiotensin converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), betablocker,and diuretics. (8)Written informed consent by his/her own will.
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of FGF23 and Klotho from baseline after 24 week treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)1) FGF23/Klotho associated factors (FGF21,FGF19 etc) at baseline, after 24 weeks, and the amount of change and %change from baseline 2) Values of the following cardiovascular function parameters at baseline, after 24 weeks, and the amount of change and %change from baseline (arbitrary items) Echocardiography, cardiovascular examination, blood pressure, heart rate | — |
Countries
Japan
Contacts
Public ContactYumiko Kanzaki
Osaka Medical College Department of Cardiology
Outcome results
None listed