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Clinical Trials/NCT00422318
NCT00422318CompletedPhase 4

Hyperuricemia and the Effects of the Uricosuric Agents Benzbromarone in Patients With Chronic Heart Failure

Tottori University Hospital1 site in 1 countryStarted: January 1, 2004Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Locations
1
Primary Endpoint
parameters of echocardiography at 16 weeks

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •chronic heart failure
  • •hyperuricemia

Exclusion Criteria

  • •renal dysfunction (Cr > 2.0 mg/dl)
  • •under treatment with anti-diabetic agents

Outcomes

Primary Outcomes

parameters of echocardiography at 16 weeks

BNP levels at 16 weeks

Secondary Outcomes

  • parameters of glucose metabolism at 16 weeks
  • Parameters of lipid metabolism at 16 weeks

Investigators

Sponsor Class
Other

Study Sites (1)

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