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Completed

NCT Number: NCT00919243

Prednisone for Heart Failure Patients With Hyperuricemia

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kunshen Liu

Shijiazhuang, Hebei, 050031, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

1 mg/kg/day with a maximum dose of 60 mg/day given orally

Allopurinol

Drug

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

Primary outcomes

  1. Change from baseline in uric acid level

    Time frame: 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hebei Medical University

Other

Registry information

Official study title

Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 12, 2009
Registry last updated
Sep 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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