Clinical trial NCT02129764: Prednisone for Heart Failure Patients With Hyperuricemia
Official title: Prednisone in Uric Acid Lowering in Symptomatic Heart Failure PATients With Hyperuricemia (PUSH-PATH Study 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure, Hyperuricemia
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 prednisone and allopurinol may have similar effect on uric acid (UA) lowering in symptomatic heart failure patients with hyperuricemia, but prednisone may be superior over allopurinol in renal function improvement. Thus the investigators design this randomized head to head study to test their hypothesis that prednisone is superior over allopurinol in renal function improvement despite their similar effect on UA lowering in heart failure patients with hyperuricemia.

Detailed description: Hyperuricemia in heart failure (HF) is linked to renal impairment, hemodynamic compromise, and inflammation. Hyperuricemic HF patients are characterized by worsening of renal function and fragile volume state, both of which restrict the use of non-steroidal anti-inflammatory drugs (NSAIDs) when treating concurrent inflammatory diseases. Recent small studies suggest that steroidal anti-inflammatory drug, prednisone, may have renal protective, UA lowering, and potentiating diuretic effects in hyperuricemic HF patients. However, general acceptance of prednisone as a treatment option for anti-inflammation therapy in patients with hyperuricemic HF requires more safety data. We therefore designed a randomized study to compare the safety and renal protective effects of short-term use of prednisone with allopurinol, a widely used xanthine oxidase inhibitor with a well-established safety profile in HF, in hyperuricemic HF patients.

Eligibility criteria: Inclusion Criteria:

* chronic congestive heart failure
* 18-80 years old
* NYHA Class II-IV
* Serum uric acid \> 7mg/dl
* left ventricular ejection fraction ≤ 45%

Exclusion Criteria:

* Acute gouty arthritis;
* Any condition (other than heart failure) that could limit the use of prednisone or xanthine oxidase inhibitors;
* Acute decompensated heart failure;
* Any concurrent disease that likely limits life expectancy;
* Active myocarditis, or an hypertrophic obstructive or restrictive cardiomyopathy;
* Myocardial infarction, stroke, unstable angina, or cardiac surgery within the previous 3 months;
* Indication for hemodialysis
* Creatinine\> 3.0 mg per deciliter at admission to the hospital
* Uncontrolled systolic blood pressure \> 140 mmHg
* Known bilateral renal artery stenosis
* Complex congenital heart disease
* Any signs of infections
* Enrollment in another clinical trial involving medical or device-based interventions

Primary outcomes:
measure: Change from baseline in serum creatinine levels
timeFrame: 2 weeks
Secondary outcomes:
measure: Change from baseline in uric acid levels
timeFrame: 2 weeks
measure: Change from baseline in Cystatin C
timeFrame: 2 weeks
measure: the levels of tumor necrosis factor (TNF) alfa,IL-6 in the circulation, high-sensitivity C-reactive Protein (hs-CRP)
timeFrame: 2 weeks
measure: The levels of angiotensin II and aldosterone in the circulation.
timeFrame: 2 weeks
measure: Daily urine output
timeFrame: 2 weeks
measure: New York Heart Association (NYHA) functional class
timeFrame: 2 weeks
measure: 24h urinary sodium excretion
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shijiazhuang
country: China
state: Hebei
Study officials:
References: