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Prednisone for Heart Failure Patients With Hyperuricemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00919243
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : September 1, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Hyperuricemia Drug: prednisone Drug: allopurinol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia
Study Start Date : February 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: prednisone Drug: prednisone
1 mg/kg/day with a maximum dose of 60 mg/day given orally

Active Comparator: allopurinol Drug: allopurinol
allopurinol, the dose of allopurinol is adjusted by patients' renal function, and with a maximum dose of 300mg/day.

Primary Outcome Measures :
  1. Change from baseline in uric acid level [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in creatinine clearance rate [ Time Frame: 4 weeks ]
  2. Daily urine volume [ Time Frame: 4 weeks ]
  3. Body weight [ Time Frame: 4 weeks ]
  4. patient assessed dyspnea and physician assessed global clinical status [ Time Frame: 4 weeks ]
  5. 6-minute walking distance [ Time Frame: 4 weeks ]
  6. NYHA functional class [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00919243

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China, Hebei
Kunshen Liu
Shijiazhuang, Hebei, China, 050031
Sponsors and Collaborators
Hebei Medical University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor, The First Hospital of Hebei Medical University Identifier: NCT00919243    
Other Study ID Numbers: hebmu 08-12
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: September 1, 2010
Last Verified: June 2009
Keywords provided by Hebei Medical University:
heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents