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Prednisone for Heart Failure Patients With Hyperuricemia

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ClinicalTrials.gov Identifier: NCT00919243
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : September 1, 2010
Sponsor:
Information provided by:

Study Description
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

Study Design

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
Primary Completion Date : July 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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


Locations
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 Posted: June 12, 2009    Key Record Dates
Last Update Posted: September 1, 2010
Last Verified: June 2009

Keywords provided by Hebei Medical University:
prednisone
allopurinol
heart failure
hyperuricemia

Additional relevant MeSH terms:
Heart Failure
Hyperuricemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Prednisone
Allopurinol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents