UMIN-CTR Clinical Trial

Public title

the effect of febuxostat on vascular endothelial function in subjects with hyperuricemia and ischemic heart disease

Acronym

the effect of febuxostat on vascular endothelial function in subjects with hyperuricemia and ischemic heart disease

Scientific Title

the effect of febuxostat on vascular endothelial function in subjects with hyperuricemia and ischemic heart disease

Scientific Title:Acronym

the effect of febuxostat on vascular endothelial function in subjects with hyperuricemia and ischemic heart disease

Region

Japan

Condition

hyperuricemia and ischemic heart disease

Classification by specialty

Cardiology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To asess the effect of febuxostat on vascular endothelial function,oxidative stress marker,exercise capacity,cardiac function in subjects with hyperuricemia and ischemic heart disease.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The amount of change of the RH-PAT index

Key secondary outcomes

1.the amount of change of serum uric acid value
2.achievement quotient of serum uric acid level under 6.0mg/dl
3.the amount of change of eGFR
4.the amount of change of BNP level
5.the amount of change of the level of maker of inflammation
6.the amount of change of the level of maker of oxidative stress
7.cadiac function indexes on echocardiography
8.change in exercise capacity indexes
9.simptom of angina pectoris
10.the amount of change of fasting blood glucose level and HbA1c

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Lifestyle adjustment

Interventions/Control_2

febuxostat administration

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

subjects must match all conditions below.
1.patients with serum uric acid level over 7.0mg/dl.
2.patients with ischemic heart disease.
3.patients older than 20 years old.
4.patients agreed with consent form.

Key exclusion criteria

1.patients with a history of hypersensitivity to febuxostat.
2.patients with AST or ALT level over than the twice the facilitie standard value.
3.patients with severe renal dysfunction(eGFR under 15 mL/min./1.73m2 or hemodialysis patients).
4.patients received the uric acid descent medicine within two weeks before competent judgment.
5.patients within 1weeks from onset of acute myocardial infarction.
6.patients underwent CABG and after radial artery graft excision.
7. patients with malignant tumor or past history of malignant tumor (except patients with no recurrence or who didn't need specialized treatment for malignant tumor within 5 recent years).
8.patients who take mercaptopurine hydrate
,azathioprine,pyrazinamide or ethambutol.
9.patients participated to other clinical trials within recent 6 months.
10.patients judged not to be suitable as a subject by attending doctor. Especially, patients with serum uric acid level over 9mg/dl should be considered about not to participate to this trial.

Target sample size

62

Name of lead principal investigator

1st name
Middle name
Last name	Masaharu Ishihara

Organization

National Cerebral and Cardiovascular Center.

Division name

Division of Cardiology

Zip code

Address

5-7-1,Fujishirodai,Suita city,Osaka,Japan

TEL

06-6833-5012

Email

ishihara.masaharu.hp@mail.ncvc.go.jp

Name of contact person

1st name
Middle name
Last name	Reiko Fujiwara

Organization

National Cerebral and Cardiovascular Center.

Division name

Division of Cardiology

Zip code

Address

5-7-1,Fujishirodai,Suita city,Osaka,Japan

TEL

06-6833-5012

Homepage URL

Email

reikofuj@hsp.ncvc.go.jp

Institute

National Cerebral and Cardiovascular Center.

Institute

Department

Personal name

Organization

National Cerebral and Cardiovascular Center.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

none

Name of secondary funder(s)

none

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立循環器病研究センター

Date of disclosure of the study information

2013

Year

11

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2013

Year

10

Month

19

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

11

Month

19

Day

Last modified on

2014

Year

08

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014392