Prednisone for Heart Failure Patients With Hyperuricemia
Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 heart-failure
Started Feb 2009
Shorter than P25 for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 11, 2009
CompletedFirst Posted
Study publicly available on registry
June 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedSeptember 1, 2010
June 1, 2009
1.4 years
June 11, 2009
August 31, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in uric acid level
4 weeks
Secondary Outcomes (6)
Change from baseline in creatinine clearance rate
4 weeks
Daily urine volume
4 weeks
Body weight
4 weeks
patient assessed dyspnea and physician assessed global clinical status
4 weeks
6-minute walking distance
4 weeks
- +1 more secondary outcomes
Study Arms (2)
prednisone
EXPERIMENTALallopurinol
ACTIVE COMPARATORInterventions
allopurinol, the dose of allopurinol is adjusted by patients' renal function, and with a maximum dose of 300mg/day.
Eligibility Criteria
You may qualify if:
- years old
- NYHA Class III-IV
- EF =\< 40%
- Uric acid =\> 9.5 mg/dL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kunshen Liu
Shijiazhuang, Hebei, 050031, China
Related Publications (1)
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.
PMID: 23395281DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 11, 2009
First Posted
June 12, 2009
Study Start
February 1, 2009
Primary Completion
July 1, 2010
Study Completion
August 1, 2010
Last Updated
September 1, 2010
Record last verified: 2009-06