Prednisone for Heart Failure Patients With Hyperuricemia

Phase 4

Completed

• Conditions: Heart Failure; Hyperuricemia
• Interventions: Drug: allopurinol; Drug: prednisone

• Registration Number: NCT00919243
• Lead Sponsor: Hebei Medical University

Brief Summary

Hyperuricemia is a very common finding in patients with heart failure. It is usually related to diuretic use and deteriorated renal function. The recently evidence showed that uric acid (UA) lowering therapy may improve clinical status in symptomatic heart failure patients with hyperuricemia. In their clinical practice, the investigators found that glucocorticoids could dramatically lower UA while improving renal function. Thus the investigators design this randomized head to head study to test our hypothesis that prednisone have the same efficacy to allopurinol on lowering UA and could improve renal function at the same time.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Status Verified: 2009-06
• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Last Update Submitted: 2010-08-31
• Last Update Posted: 2010-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18-70 years old
• NYHA Class III-IV
• EF =< 40%
• Uric acid => 9.5 mg/dL

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Exclusion Criteria

• Acute gouty arthritis
• Any condition (other than CHF) that could limit the use of prednisone or allopurinol
• Any concurrent disease likely to limit life expectancy.
• Active myocarditis, or an obstructive or restrictive cardiomyopathy
• Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
allopurinol	allopurinol	-
prednisone	prednisone	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in uric acid level	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in creatinine clearance rate	4 weeks
Daily urine volume	4 weeks
Body weight	4 weeks
patient assessed dyspnea and physician assessed global clinical status	4 weeks
6-minute walking distance	4 weeks
NYHA functional class	4 weeks

Trial Locations

Locations (1)

Kunshen Liu; 🇨🇳 Shijiazhuang, Hebei, China