UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010270 |
|---|---|
| Receipt number | R000012020 |
| Scientific Title | Effects of febuxostat on cardiorenal function in patients with heart failure and hyperuricemia |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2018/10/12 12:34:02 |
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Basic information
Public title
Effects of febuxostat on cardiorenal function in patients with heart failure and hyperuricemia
Acronym
EFFECT Study
Scientific Title
Effects of febuxostat on cardiorenal function in patients with heart failure and hyperuricemia
Scientific Title:Acronym
EFFECT Study
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of febuxostat on renal function in patients with heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Improvement of eGFR
Key secondary outcomes
Cardiac function
Anemia
Inflammatory marker
Cardiac event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
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
Interventions/Control_2
conventional therapy
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
NYHA class II-IV with hyperuricemia
Already receiving standard medical therapies
No limit for LVEF
Age=20 or more
Stable inpatient or outpatient
Key exclusion criteria
Contraindication for febuxostat
Already receiving medications for hyperuricemia
Severe liver dysfunction
eGFR<30ml/min/1.73m2
Malignant neoplasm
Does not provide IC
Essential to give medication for hyperuricemia
Others
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yoshikawa |
Organization
Sakakibara Heart Institute
Division name
Department of Cardiology
Zip code
Address
3-16-1 Asahicho, Fuchu, Japan
TEL
042-314-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yoshikawa |
Organization
Sakakibara Heart Institute
Division name
Department of Cardiology
Zip code
Address
3-16-1 Asahicho, Fuchu, Japan
TEL
042-314-3111
Homepage URL
tyoshi@shi.heart.or.jp
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
Japan Promotion Society for Cardiovascular Diseases
Organization
Division
Category of Funding Organization
Non profit foundation
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
公益財団法人日本心臓血圧研究振興会付属榊原記念病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 18 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012020
