Chronic heart failure patients with hyperuricemia
Conditions
Sponsors
LEAF-CHF steering committee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Male or female patients over 20 years old at time stable chronic heart failure 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 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 BNP from baseline after 24 week treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| (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. | — |
Countries
Japan
Contacts
Public ContactMao Kakinoki
Hubit genomix, Inc. Business Promotion Unit
Outcome results
None listed