- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00422318
Treatment of Hyperuricemia in Patients With Heart Failure
January 12, 2007 updated by: Tottori University Hospital
Hyperuricemia and the Effects of the Uricosuric Agents Benzbromarone in Patients With Chronic Heart Failure
The study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and (II) to test the effect of lowering UA by uricosuric treatment in CHF.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hyperuricemia is often observed in patients with congestive heart failure (CHF).
It has been reported that hyperuricemia is related to exercise capacity, inflammation markers and diastolic dysfunction in such patients.
In addition, hyperuricemia in CHF relates to both symptomatic status (i.e.
morbidity) as well as impaired prognosis (i.e.
mortality).
Hyperuricemia is likely to play an important role in the pathophysiology of CHF.
Up-regulation of xanthine oxidase (XO) activity in CHF has been shown to contribute to higher uric acid (UA) in CHF and the therapeutic concept of XO inhibition has shown beneficial effects in a number of surrogate markers in these patients.
The XO inhibition accounts for substantial decrease in oxygen radical load, the latter is discussed as the main benefit of XO inhibition treatment in hyperuricemic patients.
However, whether high uric acid itself is important or merely a marker of XO activity (and hence of increased radical accumulation) is currently under discussion.
Therefore, this study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and (II) to test the effect of lowering UA by uricosuric treatment in CHF.
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Yonago, Japan, 683-8504
- Tottori University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic heart failure
- hyperuricemia
Exclusion Criteria:
- renal dysfunction (Cr > 2.0 mg/dl)
- under treatment with anti-diabetic agents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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parameters of echocardiography at 16 weeks
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BNP levels at 16 weeks
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Secondary Outcome Measures
Outcome Measure |
|---|
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parameters of glucose metabolism at 16 weeks
|
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Parameters of lipid metabolism at 16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion
December 1, 2005
Study Registration Dates
First Submitted
January 12, 2007
First Submitted That Met QC Criteria
January 12, 2007
First Posted (Estimate)
January 15, 2007
Study Record Updates
Last Update Posted (Estimate)
January 15, 2007
Last Update Submitted That Met QC Criteria
January 12, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #345
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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