Prednisone in Uric Acid Lowering in Symptomatic Heart Failure PATients With Hyperuricemia (PUSH-PATH Study 2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 205
- 主要终点
- Change from baseline in serum creatinine levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic congestive heart failure
- •18-80 years old
- •NYHA Class II-IV
- •Serum uric acid > 7mg/dl
- •left ventricular ejection fraction ≤ 45%
排除标准
- •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
研究组 & 干预措施
Prednisone
Prednisone will be given 30mg/day for 2 weeks and then tapered off.
干预措施: Prednisone (Drug)
Allopurinol
Allopurinol will be given 100 mg/day initially, and then titrated to 200 mg/day.
干预措施: Allopurinol (Drug)
结局指标
主要结局
Change from baseline in serum creatinine levels
时间窗: 2 weeks
Change from baseline in serum creatinine levels at the end of study, i.e. 2 weeks
次要结局
- Change from baseline in Cystatin C(2 weeks)
- the levels of tumor necrosis factor (TNF) alfa,IL-6 in the circulation, high-sensitivity C-reactive Protein (hs-CRP)(2 weeks)
- The levels of angiotensin II and aldosterone in the circulation.(2 weeks)
- Change from baseline in uric acid levels(2 weeks)
- New York Heart Association (NYHA) functional class(2 weeks)
- 24h urinary sodium excretion(2 weeks)
- Daily urine output(2 weeks)
研究者
Kun-shen Liu M.D.
Professor
Hebei Medical University