Prednisone for Heart Failure Patients With Hyperuricemia
Primary Purpose
Heart Failure, Hyperuricemia
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
prednisone
allopurinol
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring prednisone, allopurinol, heart failure, hyperuricemia
Eligibility 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
Sites / Locations
- Kunshen Liu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
prednisone
allopurinol
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in uric acid level
Secondary Outcome Measures
Change from baseline in creatinine clearance rate
Daily urine volume
Body weight
patient assessed dyspnea and physician assessed global clinical status
6-minute walking distance
NYHA functional class
Full Information
NCT ID
NCT00919243
First Posted
June 11, 2009
Last Updated
August 31, 2010
Sponsor
Hebei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00919243
Brief Title
Prednisone for Heart Failure Patients With Hyperuricemia
Official Title
Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hebei Medical University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Hyperuricemia
Keywords
prednisone, allopurinol, heart failure, hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prednisone
Arm Type
Experimental
Arm Title
allopurinol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
1 mg/kg/day with a maximum dose of 60 mg/day given orally
Intervention Type
Drug
Intervention Name(s)
allopurinol
Intervention Description
allopurinol, the dose of allopurinol is adjusted by patients' renal function, and with a maximum dose of 300mg/day.
Primary Outcome Measure Information:
Title
Change from baseline in uric acid level
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in creatinine clearance rate
Time Frame
4 weeks
Title
Daily urine volume
Time Frame
4 weeks
Title
Body weight
Time Frame
4 weeks
Title
patient assessed dyspnea and physician assessed global clinical status
Time Frame
4 weeks
Title
6-minute walking distance
Time Frame
4 weeks
Title
NYHA functional class
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kunshen Liu
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050031
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23395281
Citation
Liu C, Zhao Q, Zhen Y, Gao Y, Tian L, Wang L, Ji L, Liu G, Ji Z, Liu K. Prednisone in Uric Acid lowering in Symptomatic Heart Failure Patients With Hyperuricemia (PUSH-PATH) study. Can J Cardiol. 2013 Sep;29(9):1048-54. doi: 10.1016/j.cjca.2012.11.008. Epub 2013 Feb 6.
Results Reference
derived
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Prednisone for Heart Failure Patients With Hyperuricemia
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