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Prednisone for Heart Failure Patients With Hyperuricemia

This study has been completed.
Sponsor:
Information provided by:
Hebei Medical University
ClinicalTrials.gov Identifier:
NCT00919243
First received: June 11, 2009
Last updated: August 31, 2010
Last verified: June 2009
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hebei Medical University:

Primary Outcome Measures:
  • Change from baseline in uric acid level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in creatinine clearance rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Daily urine volume [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Body weight [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • patient assessed dyspnea and physician assessed global clinical status [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 6-minute walking distance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • NYHA functional class [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919243

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

No publications provided

Responsible Party: Professor, The First Hospital of Hebei Medical University
ClinicalTrials.gov Identifier: NCT00919243     History of Changes
Other Study ID Numbers: hebmu 08-12
Study First Received: June 11, 2009
Last Updated: August 31, 2010
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013