Treatment of Hyperuricemia in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422318
• Other study ID #: #345
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2007
• Last updated: January 12, 2007
• Start date: January 2004
• Est. completion date: December 2005

Study information

• Verified date: January 2007
• Source: Tottori University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2005
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• chronic heart failure

• hyperuricemia

Exclusion Criteria:

• renal dysfunction (Cr > 2.0 mg/dl)

• under treatment with anti-diabetic agents

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Hyperuricemia

Intervention

Drug:
• Benzbromarone (drug)

Locations

Country	Name	City	State
Japan	Tottori University Hospital	Yonago

Sponsors (1)

Lead Sponsor	Collaborator
Tottori University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	parameters of echocardiography at 16 weeks
Primary	BNP levels at 16 weeks
Secondary	parameters of glucose metabolism at 16 weeks
Secondary	Parameters of lipid metabolism at 16 weeks