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Prednisone for Heart Failure Patients With Hyperuricemia

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 12, 2009
Last Update Posted: September 1, 2010
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.
Information provided by:
Hebei Medical University
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 Intervention Phase
Heart Failure Hyperuricemia Drug: prednisone Drug: allopurinol Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hebei Medical University:

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

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

Estimated Enrollment: 40
Study Start Date: February 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00919243

China, Hebei
Kunshen Liu
Shijiazhuang, Hebei, China, 050031
Sponsors and Collaborators
Hebei Medical University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor, The First Hospital of Hebei Medical University
ClinicalTrials.gov Identifier: NCT00919243     History of Changes
Other Study ID Numbers: hebmu 08-12
First Submitted: June 11, 2009
First Posted: June 12, 2009
Last Update Posted: September 1, 2010
Last Verified: June 2009

Keywords provided by Hebei Medical University:
heart failure

Additional relevant MeSH terms:
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