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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN C000000426
Receipt No. R000000517
Scientific Title A randomized trial to evaluate the cardioprotective effect of the uric acid-lowering therapy for hyperuricemia in patients with chronic heart failure
Date of disclosure of the study information 2006/06/01
Last modified on 2016/09/06

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Basic information
Public title A randomized trial to evaluate the cardioprotective effect of the uric acid-lowering therapy for hyperuricemia in patients with chronic heart failure
Acronym A randomized trial to evaluate the cardioprotective effect of uric acid-lowering therapy for hyperuricemia in patients with chronic heart failure
Scientific Title A randomized trial to evaluate the cardioprotective effect of the uric acid-lowering therapy for hyperuricemia in patients with chronic heart failure
Scientific Title:Acronym A randomized trial to evaluate the cardioprotective effect of uric acid-lowering therapy for hyperuricemia in patients with chronic heart failure
Region
Japan

Condition
Condition Hyperuricemia in patients with chronic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the cardioprotective effect of uric acid-lowering therapy for hyperuricemia in patients with chronic heart failure by comparing between benzbromarone, allopurinol and life-style modification treatments.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) The plasma BNP levels
2) The plasma levels of markers of oxidative stress
3) The plasma levels of pro-inflammatory cytokines
Key secondary outcomes 1) NYHA functional class
2) Hospitalizaion for worsening heart failure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Benzbromarone (25-75 mg daily) for 4 months
Interventions/Control_2 Allopurinol (100-300mg daily) for 4 months
Interventions/Control_3 Life-style modification
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 The patients who have stable left ventricular systolic dysfunction (fractional shortening <25%) and hyperuricemia (serum uric acid >=8.0 mg/dl)
Key exclusion criteria 1) Gouty arthritis or tophus
2) Patients who have already taken the uric acid-lowering drugs
3) Renal dysfunction (serum creatinin >=2.0 mg/dl)
4) Urinary or renal calculus
5) Hepatic dysfunction (GPT (ALT) >=50 IU/l)
6) Patients who do not agree and whom physician judges inappropriate to this trial for any reason
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Kitakaze
Organization National Cardiovascular Center
Division name Cardiovascular Division
Zip code
Address 5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, JAPAN
TEL 06-6833-5012
Email asamasa@xd5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Asakura
Organization National Cardiovascular Center
Division name Cardiovascular Clinical Research Center
Zip code
Address 5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, JAPAN
TEL 06-6833-5012
Homepage URL
Email asamasa@xd5.so-net.ne.jp

Sponsor
Institute National Cardiovascular Center
Institute
Department

Funding Source
Organization Japan Cardiovascular Research Foundation
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

Other administrative information
Date of disclosure of the study information
2006 Year 06 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 Suspended
Date of protocol fixation
2006 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2007 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 06 Month 01 Day
Last modified on
2016 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000517

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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