UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017678 |
|---|---|
| Receipt number | 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 12:28:34 |
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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
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
in3089@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of Cardiology
Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020463
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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