UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000426 |
|---|---|
| Receipt number | 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 | 2022/02/19 10:43:55 |
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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 | 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
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
asamasa@xd5.so-net.ne.jp
Sponsor or person
Institute
National Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000517
