UMIN-CTR Clinical Trial

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 Masafumi Middle name Last name Kitakaze
Organization	National Cardiovascular Center
Division name	Cardiovascular Division
Zip code	565-8565
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 Masanori Middle name Last name Asakura
Organization	National Cardiovascular Center
Division name	Cardiovascular Clinical Research Center
Zip code	565-8565
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	National Cardiovascular Center
Address	5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, JAPAN
Tel	06-6833-5012
Email	kitakaze@zf6.so-net.ne.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

Other administrative information
Date of disclosure of the study information	2006 Year 06 Month 01 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/29507373/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/29507373/
Number of participants that the trial has enrolled	213
Results	We found that the estimated and actual occurrence possibility of cardiovascular events were well linked.
Results date posted	2022 Year 02 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	patients hospitalized due to acute HF
Participant flow	We prospectively enrolled 213 patients with ADHF admitted between May 2013 and March 2015 in three different hospitals of National Cerebral and Cardiovascular Center (n = 114) and Hokkaido (n = 80) and Kyushu Universities (n = 19) and followed up these patients until the time of cardiovascular events or the end of April 2016.
Adverse events	cardiovascular events
Outcome measures	the time of cardiovascular events
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 01 Month 23 Day
Date of IRB	2006 Year 06 Month 01 Day
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	2022 Year 02 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000517