Unique ID issued by UMIN | UMIN000013330 |
---|---|
Receipt number | R000015556 |
Scientific Title | Effect of urate LowEring Agent Febuxostat in Chronic Heart Failure patients with hyperuricemia |
Date of disclosure of the study information | 2014/03/04 |
Last modified on | 2019/02/28 09:28:03 |
Effect of urate LowEring Agent Febuxostat
in Chronic Heart Failure patients with hyperuricemia
LEAF-CHF study
Effect of urate LowEring Agent Febuxostat
in Chronic Heart Failure patients with hyperuricemia
LEAF-CHF study
Japan |
Chronic heart failure patients with hyperuricemia
Cardiology |
Others
NO
To evaluate the efficacy of Febuxostat, a urate lowering agent, on BNP in patients with chronic heart failure (CHF) (NYHA functional class II and III) and hyperuricemia.
Efficacy
Confirmatory
Explanatory
Not applicable
The change of BNP from baseline after 24 week treatment
(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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Febuxostat administration for 24 weeks
Follow-up for 24 weeks
20 | years-old | <= |
Not applicable |
Male and Female
(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.
(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.
200
1st name | |
Middle name | |
Last name | Hiroyuki Tsutsui |
Kyushu University Graduate School of Medicine
Department of Cardiovascular Medicine
Umade3-1-1, Higashi-ku, Fukuoka, 812-8582
092-642-5360
htsutsui@cardiol.med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Mao Kakinoki |
Hubit genomix, Inc.
Business Promotion Unit
Tukiji-Ogawa Building 3F, 7-10-2 Tukiji, Chuo-ku, Tokyo 104-0045, Japan
03-5148-3992
mkakinoki@hubitgenomix.com
LEAF-CHF steering committee
TEIJIN PHARMA LIMITED.
Profit organization
Japan
NO
北海道大学病院 循環器内科(北海道)、札幌医科大学附属病院 第2内科(北海道)、医療法人社団慈弘会 ハートサウンズもりクリニック 内科・循環器(北海道)、防衛医科大学校病院 循環器内科(埼玉県)、東京医科歯科大学医学部附属病院 循環器内科(東京都)、東京大学医学部附属病院 循環器内科(東京都)、北里大学病院 循環器内科(神奈川県)、聖マリアンナ医科大学病院 循環器内科(神奈川県)、名古屋大学医学部附属病院 循環器内科(愛知県)、西尾市民病院 内科(循環器)(愛知県)、名古屋市立大学病院 循環器内科(愛知県)、大阪大学医学部附属病院 循環器内科(大阪府)、地方独立行政法人大阪府立病院機構大阪府立急性期・総合医療センター 心臓内科(大阪府)、大阪医科大学附属病院 循環器内科(大阪府)、特定医療法人渡辺医学会 桜橋渡辺病院 循環器内科(大阪府)、兵庫医科大学病院 循環器内科(兵庫県)、奈良県立医科大学附属病院 循環器・腎臓・代謝内科(奈良県)、岡山大学病院 循環器内科(岡山県)、広島大学病院 循環器内科(広島県)、鳥取大学医学部附属病院 循環器内科(鳥取県)、山口大学医学部附属病院 第二内科(山口県)、東北大学病院 循環器内科 (宮城県)、自治医科大学附属さいたま医療センター 循環器科 (埼玉県)、東京慈恵会医科大学附属病院 循環器内科 (東京都)、公立陶生病院 循環器内科 (愛知県)、国立循環器病研究センター 心臓血管内科 (大阪府)、公益財団法人日本心臓血圧研究振興会附属 榊原記念病院 循環器内科 (東京都)、国家公務員共済組合連合会 虎の門病院 循環器センター (東京都)、九州大学病院 循環器内科 (福岡県)、独立行政法人労働者健康福祉機構山陰労災病院 第二循環器科 (鳥取県)、広島鉄道病院 循環器内科 (広島県)、藤井政雄記念病院 循環器内科 (鳥取県)、県立広島病院 循環器内科 (広島県)、社会福祉法人北海道社会事業協会小樽病院 循環器科 (北海道)、昭和大学病院 循環器内科 (東京都)、市立札幌病院 循環器科 (北海道)、徳山中央病院(山口県)、京都大学(京都府)、済生会山口総合病院(山口県)、山口県立総合医療センター(山口県)
2014 | Year | 03 | Month | 04 | Day |
Unpublished
Completed
2014 | Year | 07 | Month | 14 | Day |
2014 | Year | 08 | Month | 01 | Day |
2018 | Year | 06 | Month | 30 | Day |
2018 | Year | 06 | Month | 30 | Day |
2018 | Year | 12 | Month | 28 | Day |
2019 | Year | 02 | Month | 21 | Day |
2014 | Year | 03 | Month | 04 | Day |
2019 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015556
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