Prednisone for Heart Failure Patients With Hyperuricemia

Heart Failure Clinical Trial

Official title:

Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919243
• Other study ID #: hebmu 08-12
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2009
• Last updated: August 31, 2010
• Start date: February 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2009
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Hyperuricemia

Intervention

Drug:
• prednisone
1 mg/kg/day with a maximum dose of 60 mg/day given orally
• allopurinol
allopurinol, the dose of allopurinol is adjusted by patients' renal function, and with a maximum dose of 300mg/day.

Locations

Country	Name	City	State
China	Kunshen Liu	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in uric acid level		4 weeks	No
Secondary	Change from baseline in creatinine clearance rate		4 weeks	Yes
Secondary	Daily urine volume		4 weeks	Yes
Secondary	Body weight		4 weeks	No
Secondary	patient assessed dyspnea and physician assessed global clinical status		4 weeks	No
Secondary	6-minute walking distance		4 weeks	No
Secondary	NYHA functional class		4 weeks	No