NCT00422318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
Last Updated

January 15, 2007

Status Verified

January 1, 2007

First QC Date

January 12, 2007

Last Update Submit

January 12, 2007

Conditions

Heart FailureHyperuricemia

Keywords

Heart FailureInsulinMetabolismPharmacologyUric Acid

Outcome Measures

Primary Outcomes (2)

  • parameters of echocardiography at 16 weeks

  • BNP levels at 16 weeks

Secondary Outcomes (2)

  • parameters of glucose metabolism at 16 weeks

  • Parameters of lipid metabolism at 16 weeks

Interventions

Benzbromarone (drug)DRUG

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • chronic heart failure
  • hyperuricemia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tottori University Hospital

Yonago, 683-8504, Japan

Location

Related Publications (1)

  • Ogino K, Kato M, Furuse Y, Kinugasa Y, Ishida K, Osaki S, Kinugawa T, Igawa O, Hisatome I, Shigemasa C, Anker SD, Doehner W. Uric acid-lowering treatment with benzbromarone in patients with heart failure: a double-blind placebo-controlled crossover preliminary study. Circ Heart Fail. 2010 Jan;3(1):73-81. doi: 10.1161/CIRCHEARTFAILURE.109.868604. Epub 2009 Nov 20.

    PMID: 19933411DERIVED

MeSH Terms

Conditions

Heart FailureHyperuricemiaInsulin Resistance

Interventions

BenzbromaronePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kazuhide Ogino, MD

    Tottori University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2007

First Posted

January 15, 2007

Study Start

January 1, 2004

Study Completion

December 1, 2005

Last Updated

January 15, 2007

Record last verified: 2007-01

Locations

JP(1)