UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021919 |
|---|---|
| Receipt number | R000025176 |
| Scientific Title | A study to evaluate the effect of febuxostat in heart failure patients with hyperuricemia |
| Date of disclosure of the study information | 2016/04/15 |
| Last modified on | 2021/04/23 10:00:55 |
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Basic information
Public title
A study to evaluate the effect of febuxostat in heart failure patients with hyperuricemia
Acronym
A study to evaluate the effect of febuxostat in heart failure patients with hyperuricemia
Scientific Title
A study to evaluate the effect of febuxostat in heart failure patients with hyperuricemia
Scientific Title:Acronym
A study to evaluate the effect of febuxostat in heart failure patients with hyperuricemia
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of febuxostat, particularly on endothelial function, in heart failure patients with hyperuricemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the effect of febuxostat, particularly on endothelial function, in heart failure patients with hyperuricemia
Key secondary outcomes
To evaluate the effect of febuxostat on heart failure biomarkers in heart failure patients with hyperuricemia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
febuxostat,
Interventions/Control_2
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
Heart failure patients with hyperuricemia
Key exclusion criteria
Patients with contraindication of febuxostat
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kitaoka |
Organization
Kochi Medical School, Kochi University
Division name
Department of Cardiology and Geriatrics
Zip code
783-8505
Address
Kohasu, Nankoku-chi, Kochi-ken, JAPAN
TEL
088-880-2352
kitaokah@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Minaguchi, Tabuchi |
| Middle name | |
| Last name | Minaguchi, Tabuchi |
Organization
Kochi Medical School Hospital
Division name
Kochi Medical School Hospital
Zip code
783-8505
Address
Kohasu, Nankoku-chi, Kochi-ken, JAPAN
TEL
088-880-2352
Homepage URL
http://www.kochi-ms.ac.jp/~fm_gratr/
rinri21@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kochi Medical School Hospital
Address
Kochi Medical School Hospital
Tel
088-880-2352
rinri21@kochi-u.ac.jp
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
高知大学医学部附属病院（Kochi Medical School Hospital）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 12 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 12 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 15 | Day |
Last modified on
| 2021 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025176
