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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017678
Receipt No. R000020463
Scientific Title Effect of cardiovascular remodeling under Low Ering Agent Febuxostat in Chronic Heart Failure patients with hyperuricemia
Date of disclosure of the study information 2016/11/14
Last modified on 2017/12/24

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Basic information
Public title Effect of cardiovascular remodeling under Low Ering Agent Febuxostat
in Chronic Heart Failure patients with hyperuricemia
Acronym Effect of vascular remodeling under uric acid control in CHF patients
Scientific Title Effect of cardiovascular remodeling under Low Ering Agent Febuxostat
in Chronic Heart Failure patients with hyperuricemia
Scientific Title:Acronym Effect of vascular remodeling under uric acid control in CHF patients
Region
Japan

Condition
Condition Chronic heart failure patients with hyperuricemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Febuxostat, a urate lowering agent, on FGF23,Klotho and associated factors in patients with chronic heart failure (CHF) (NYHA functional class II and III) and hyperuricemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The change of FGF23 and Klotho from baseline after 24 week treatment
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Febuxostat administration for 24 weeks
Interventions/Control_2 Follow-up for 24 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Hoshiga
Organization Osaka Medical College
Division name Department of Cardiology
Zip code
Address 2-7 Daigakucho, Takatuski, Osaka
TEL 072-683-1221
Email in1026@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko Kanzaki
Organization Osaka Medical College
Division name Department of Cardiology
Zip code
Address 2-7 Daigakucho, Takatuski, Osaka
TEL 072-683-1221
Homepage URL
Email in3089@poh.osaka-med.ac.jp

Sponsor
Institute Department of Cardiology
Osaka Medical College
Institute
Department

Funding Source
Organization Department of Cardiology
Osaka Medical College
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪医科大学 循環器内科

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 26 Day
Last modified on
2017 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020463

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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