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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010270
Receipt No. 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

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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
Email

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
Email tyoshi@shi.heart.or.jp

Sponsor
Institute Sakakibara Heart Institute
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012020

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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